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Hazard Analysis and Risk-Based
Preventive Controls for Human Food:
Draft Guidance for Industry
1
This draft guidance, when finalized, will represent the current thinking of the Food and Drug
Administration (FDA or we) on this topic. It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. To discuss an alternative approach,
contact FDA’s Technical Assistance Network by submitting your question at
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-technical-assistance-
network-tan.
Appendix 1: Known or Reasonably Foreseeable Hazards
(“Potential Hazards”)
Table of Contents
A1.1 Purpose of Appendix 1
A1.2 Terms, Abbreviations, and Resources
A1.3 Requirement for a Hazard Analysis
A1.4 How We Developed Appendix 1
A1.5 Organization of Appendix 1
A1.5.1 Food Groups Addressed by Appendix 1
A1.5.2 Tables of Known or Reasonably Foreseeable Hazards (“Potential Hazards”)
A1.5.3 Organization of Each Table in Appendix 1
A1.5.4 The Food Subcategories in the Tables in Appendix 1 Address Raw Materials,
Other Ingredients, and Multi-Component Foods
A1.5.5 Food Categories/Food Subcategories that Are LACF
A1.5.6 Infant Formula and Other Foods for Infants and Toddlers
1
This guidance has been prepared by the Office of Food Safety in the Center for Food Safety and
Applied Nutrition at the U.S. Food and Drug Administration.
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A1.6 Tables of Known or Reasonably Foreseeable Hazards (“Potential
Hazards”) in Appendix 1
A1.6.1 Food-Related Biological Hazards
A1.6.1.1 The most relevant food-related biological hazards
A1.6.1.2 Note about viruses, parasites, and Shigella spp.
A1.6.1.2.1 Viruses and parasites
A1.6.1.2.2 Shigella spp.
A1.6.1.3 Note about biological hazards in food subcategories manufactured using
exceptionally lethal processes
A1.6.1.4 Note about biological hazards in products produced in establishments that are
under the jurisdiction of USDA
A1.6.1.5 Note about biological hazards in infant formula and other foods for infants and
toddlers
A1.6.1.6 Note about biological hazards in food products produced using ingredients that
are pasteurized or otherwise treated to control biological hazards
A1.6.1.7 Note about biological hazards in food products that consumers cook
A1.6.2 Food-Related Chemical Hazards
A1.6.2.1 The most relevant food-related chemical hazards
A1.6.2.2 Note about food allergen hazards and substances associated with a food
intolerance or food-related disease
A1.6.2.3 Note about radiological hazards, dioxins, PCBs, and toxic elements
A1.6.2.4 Note about unapproved food and color additives
A1.6.2.5 Note about toxic element hazards in foods for infants and toddlers, including
infant formula
A1.6.2.6 Note about mycotoxin hazards
A1.7 Process-related Hazards and Facility-related Hazards
A1.7.1 The Most Relevant Process-related and Facility-related Biological Hazards
A1.7.2 The Most Relevant Process-related Chemical Hazards
A1.7.3 The Most Relevant Process-related Physical Hazards
A1.8 How to Use the Tables in Appendix 1
A1.8.1 Appendix 1 Reflects a Tiered Approach to the Requirements for Hazard
Analysis
A1.8.2 Hazards that SMEs Recommended Be Identified as Known or Reasonably
Foreseeable Hazards (“Potential Hazards”) Might Not Apply to All Food
Products in a Food Subcategory
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A1.8.3 Each Facility Determines, Through Its Hazard Analysis, Those Known or
Reasonably Foreseeable Hazards (“Potential Hazards”) That Require a
Preventive Control
A1.9 References
A1.10 Tables of Known or Reasonably Foreseeable (“Potential”) Food-
Related Biological Hazards
Table 1A: Known or reasonably foreseeable (“potential”) food-related biological
hazards for Bakery Items
Table 1B: Known or reasonably foreseeable (“potential”) food-related biological
hazards for Beverage Items
Table 1C: Known or reasonably foreseeable (“potential”) food-related biological
hazards for Miscellaneous Food Additives, Color Additives, and GRAS
Substances
Table 1D: Known or reasonably foreseeable (“potential”) food-related biological
hazards for Chocolate and Candy
Table 1E: Known or reasonably foreseeable (“potential”) food-related biological
hazards for Dairy
Table 1F: Known or reasonably foreseeable (“potential”) food-related biological
hazards for Dressings, Condiments, and Dips
Table 1G: Known or reasonably foreseeable (“potential”) food-related biological
hazards for Egg and Egg Products
Table 1H: Known or reasonably foreseeable (“potential”) food-related biological
hazards for Fruits and Vegetables
Table 1I: Known or reasonably foreseeable (“potential”) food-related biological
hazards for Game Meat Products
1
Table 1J: Known or reasonably foreseeable (“potential”) food-related biological
hazards for Grains, Pulses, Flours, and Starches
Table 1K: Known or reasonably foreseeable (“potential”) food-related biological
hazards for Nuts and Seeds
Table 1L: Known or reasonably foreseeable (“potential”) food-related biological
hazards for Oils and Oil Products
Table 1M: Known or reasonably foreseeable (“potential”) food-related biological
hazards for Snack Foods
1
Table 1N: Known or reasonably foreseeable (“potential”) food-related biological
hazards for Soups and Sauces
Table 1O: Known or reasonably foreseeable (“potential”) food-related biological
hazards for Spices and Herbs
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Table 1P: Known or reasonably foreseeable (“potential”) food-related biological
hazards for Food Sweeteners (Nutritive and Non-Nutritive)
A1.11 Tables of Potential Food-Related Chemical Hazards
Food Group 2A: Known or reasonably foreseeable (“potential”) food-related
chemical hazards for Bakery Items
Table 2B: Known or reasonably foreseeable (“potential”) food-related chemical
hazards for Beverage Items
Table 2C: Food Additives, Color Additives, and GRAS Substances
Table 2D: Known or reasonably foreseeable (“potential”) food-related chemical
hazards for Chocolate and Candy
Table 2E: Known or reasonably foreseeable (“potential”) food-related chemical
hazards for Dairy
Food Group 2F: Dressings, Condiments, and Dips
Table 2G: Known or reasonably foreseeable (“potential”) food-related chemical
hazards for Egg and Egg Products
Table 2H: Known or reasonably foreseeable (“potential”) food-related chemical
hazards for Fruits and Vegetables
1
Table 2I: Known or reasonably foreseeable (“potential”) food-related chemical
hazards for Game Meat Products
Table 2J: Known or reasonably foreseeable (“potential”) food-related chemical
hazards for Grains, Pulses, Flours, and Starches
Table 2K: Known or reasonably foreseeable (“potential”) food-related chemical
hazards for Nuts and Seeds
Table 2L: Known or reasonably foreseeable (“potential”) food-related chemical
hazards for Oils and Oil Products
Food Group 2M: Known or reasonably foreseeable (“potential”) food-related
chemical hazards for Snack Foods
Food Group 2N: Known or reasonably foreseeable (“potential”) food-related
chemical hazards for Soups and Sauces
Table 2O: Known or reasonably foreseeable (“potential”) food-related chemical
hazards for Spices and Herbs
Table 2P: Known or reasonably foreseeable (“potential”) food-related chemical
hazards for Food Sweeteners (Nutritive and Non-Nutritive)
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A1.1 Purpose of Appendix 1
The guidance in Appendix 1 is intended to help you identify known or reasonably foreseeable
biological, chemical, and physical hazards for each type of food manufactured, processed,
packed, or held at your facility. Identifying known or reasonably foreseeable hazards is one step
in determining, through your hazard analysis, which hazards require a preventive control. (See
21 CFR 117.130(a)(1).) Throughout this guidance:
• We use the term “potential hazard” as a synonym for “known or reasonably foreseeable
hazard” for the following reasons:
o Some users of this Appendix 1 could be more familiar with the term “potential hazard”
because “potential hazard” is used in food safety systems such as HACCP that are
similar to, but not the same as, the system of hazard analysis and risk-based preventive
controls in part 117;
o “Potential hazard” is a term that is used in some training materials to help emphasize
during training that a known or reasonably foreseeable hazard is still being evaluated to
determine whether it is a hazard requiring a preventive control for a food; and
o Form 2-B in Appendix 2 of this guidance (Hazard Analysis) uses the term “potential
hazard” as a shorthand for “known or reasonably foreseeable hazard” due to space
limitations.
2
• With the exception of Form 2-B, when appropriate, in this guidance we use
3
the combined
term “known or reasonably foreseeable hazard (“potential hazard”)” (or, depending on
context, “known or reasonably foreseeable (“potential”) hazard”) so that this guidance:
o consistently uses the term used in the regulatory text of part 117 to unambiguously direct
you to the regulatory requirements that are the subject of this guidance;
o consistently uses a term that could be more familiar to some users of this guidance; and
o consistently reminds you that a known or reasonably foreseeable hazard is still being
evaluated to determine whether it is a hazard requiring a preventive control for a food.
A1.2 Terms, Abbreviations, and Resources
See the following sections in the Introduction of this guidance for terms, abbreviations, and
resources as follows:
• Section III.A: Glossary of terms that are used in this guidance and are defined in 21 CFR
117.3;
• Section III.B: Glossary of terms that are defined for use in this guidance but are not defined
in 21 CFR 117.3;
• Section IV: Table of Abbreviations that are used in this guidance; and
2
We intend to modify Form 2-B to explain that it uses “potential hazard” as a synonym for “known or
reasonably foreseeable hazard.”
3
We intend to modify chapters already available as draft guidance to consistently use both terms.
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• Section VI: Resources that could be useful in developing and implementing your food safety
plan.
We organized the resources in section VI in the Introduction of this guidance in a series of
tables as shown in Table A1-1:
Table A1-1 Resource Tables in Section VI in the Introduction of This Guidance
Table No. in
Section VI of the
Introduction
Table Title
3 FDA Compliance Policy Guides Cited as a Resource in this Guidance
4 FDA Guidance for Industry Cited as a Resource in this Guidance
5 FDA Compliance Programs and Import Alerts Cited as a Resource in
this Guidance
6 Codex Standards, Codes of Practice, and Guidelines Cited as a
Resource in this Guidance
7 Resources for Designing Validation Studies
8 Additional Resources Cited in this Guidance
When we cite a resource that is listed in one of the tables in section VI of the Introduction of this
guidance, we refer you to the applicable Table in the Introduction for information on how to
access the resource. For example, if we cite to “CPG Sec. 555.400 Aflatoxins in Human Food:
Guidance for FDA Staff,” we refer you to Table 3 in section VI of the Introduction.
These resources are available as of the date that we make this guidance available. We have
verified the website addresses listed for these resources, as of the date that we make the
Introduction of this guidance available, but websites are subject to change over time. In addition,
the policies, recommendations, and information in these resources can change over time. We
recommend that you periodically review websites listing FDA’s CPGs, FDA’s Guidance for
Industry, FDA’s Compliance Programs and Import Alerts, and Codex Standards, Codes of
Practice, and Guidelines for new or modified policies, recommendations, and information.
A1.3 Requirement for a Hazard Analysis
Part 117 defines and uses three terms (i.e., “hazard,” “known or reasonably foreseeable
hazard,” and “hazard requiring a preventive control”) to establish a tiered approach to the
requirements for hazard analysis and risk-based preventive controls. The term “hazard’ is the
broadest of these three terms – e.g., any biological, chemical (including radiological), or physical
agent that has the potential to cause illness or injury. To conduct your hazard analysis:
• You start with the universe of all hazards that are relevant to food safety.
• Through the “hazard identification” phase of your hazard analysis, you then narrow this
universe of all hazards relevant to food safety to those hazards that are “known or
reasonably foreseeable hazards” (“potential hazards”) for each type of food manufactured,
processed, packed, or held at your facility – i.e., those biological, chemical (including
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radiological), and physical hazards that are known to be, or have the potential to be,
associated with your facility or your food. These “known or reasonably foreseeable hazards”
(“potential hazards”) are the hazards that you evaluate in your hazard analysis.
• Through the “hazard evaluation” phase of your hazard analysis, you then determine the
subset of those known or reasonably foreseeable hazards (“potential hazards”) that are
hazards requiring a preventive control – i.e., those known or reasonably foreseeable
hazards for which a person knowledgeable about the safe manufacturing, processing,
packing, or holding of food would, based on the outcome of a hazard analysis (which
includes an assessment of the severity of the illness or injury if the hazard were to occur and
the probability that the hazard will occur in the absence of preventive controls), establish
one or more preventive controls to significantly minimize or prevent the hazard in a food and
components to manage those controls (such as monitoring, corrections or corrective actions,
verification, and records) as appropriate to the food, the facility, and the nature of the
preventive control and its role in the facility's food safety system.
(See the definitions of “hazard,” “known or reasonably foreseeable hazard,” and “hazard
requiring a preventive control” in 21 CFR 117.3 and the discussion of the term “potential hazard”
in section A1.1 of this Appendix 1. See the requirement for a hazard analysis in 21 CFR
117.130.)
Chapter 2 of this guidance:
• provides an overview of the requirements for hazard analysis and recommendations for
steps to take before beginning a hazard analysis;
• describes a “Hazard Analysis Worksheet” that is a resource that you can use in conducting
your hazard analysis; and
• provides recommendations for a step-by-step approach to conducting the hazard
identification and hazard evaluation phases of the hazard analysis to determine those
known or reasonably foreseeable hazards (“potential hazards”) requiring a preventive
control. To do so, Chapter 2:
o includes a series of questions you can ask during the hazard identification phase
required by 21 CFR 117.130(b) to help narrow the universe of hazards that are relevant
to your facility and your food products to the known or reasonably foreseeable hazards
(“potential hazards”);
o provides recommendations for conducting the hazard evaluation phase required by 21
CFR 117.130(c) to determine which known or reasonably foreseeable hazards
(“potential hazards”) require a preventive control through consideration of the severity of
the illness or injury if the hazard were to occur, an evaluation of environmental
pathogens in certain circumstances, and an evaluation of a series of factors and their
effects on the safety of the finished food for the intended consumer; and
o briefly discusses the types of preventive controls (e.g., process controls, food allergen
controls, sanitation controls, and supply-chain controls) that could be applied when the
outcome of the hazard evaluation phase of the hazard analysis is that a known or
reasonably foreseeable hazard (“potential hazard”) requires a preventive control.
Chapter 3 of this guidance is an in-depth resource that provides background information about
the most relevant biological, chemical, and physical hazards that could be associated with a
facility or a food. For example, Chapter 3 includes several “Quick Reference Guides” that help
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you to identify common sources of biological, chemical, and physical hazards. However,
Chapter 3 does not provide an exhaustive compendium of biological, chemical, and physical
hazards or all known details about each biological, chemical, or physical hazard that Chapter 3
discusses.
We recommend that you use the information in Chapters 2 and 3 to help you determine which
hazards that we identify in the Tables in this Appendix as known or reasonably foreseeable
hazards (“potential hazards”) for specific types of food products are hazards requiring a
preventive control for your food products. See also the notes in sections A1.6.1 (regarding food-
related biological hazards), A1.6.2 (regarding food-related chemical hazards), and A1.7
(regarding process-related hazards and facility-related hazards).
A1.4 How We Developed Appendix 1
The PCHF requirements apply to a broad array of food products. To develop guidance on
hazards that could be known or reasonably foreseeable hazards (“potential hazards”) for
specific types of food products, we consulted subject matter experts (SMEs) within CFSAN. We
also contracted with a third-party consultant tasked to identify and retain recognized SMEs
within the food industry and academia to provide input during this process.
We consulted with CFSAN’s SMEs, and the consultant worked with its SMEs to identify 16
Food Groups and Food Categories and Food Subcategories within each Food Group. The
consultations with these SMEs included their recommendations on the most relevant hazards
that should be identified as known or reasonably foreseeable hazards (“potential hazards”) for
subsequent hazard evaluation by each facility that produces food products in the Food
Subcategories to determine which hazards require a preventive control as appropriate to the
facility and its food products. Resources that SMEs used for this purpose included scientific
publications (including information from the books of the International Commission on
Microbiological Specifications for Foods and publications from the Centers for Disease Control
and Prevention), published data from the FDA Recalls, Market Withdrawals, & Safety Alerts
Website (Table 8 in section VI of the Introduction of this guidance), published FDA databases
(such as the Pesticide Residue Monitoring Program Reports and Data (Table 8 in section VI of
the Introduction of this guidance)) and unpublished FDA databases (such as the database used
to store reports to the Reportable Food Registry
4
and FDA surveillance databases) available to
CFSAN SMEs.
In 2016, we first made Appendix 1 available as draft guidance for public comment (81 FR
57816, August 24, 2016). The 2016 draft Appendix 1 included three sets of Tables of known or
reasonably foreseeable hazards (“potential hazards”) – one for biological hazards, one for
chemical hazards, and one for process-related biological, chemical, and physical hazards. After
considering public comments, we revised Appendix 1 and are making this revised Appendix 1
available as a revised draft guidance for public comment. This revised Appendix 1 only includes
two sets of Tables of known or reasonably foreseeable hazards (“potential hazards”) – one for
biological hazards and one for chemical hazards. This revised Appendix 1 no longer includes a
table of known or reasonably foreseeable hazards (“potential hazards”) for process-related
biological, chemical, and physical hazards, because process-related hazards generally are
unique to each facility based on its operations and processes. Instead, section A1.7
recommends that each facility identify known or reasonably foreseeable (“potential”) process-
4
Aggregate information is available to the public from the FDA-TRACK: Reportable Food Registry Data
Dashboard (Table 8 in section VI of the Introduction of this guidance).
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related hazards for its products based on its knowledge, experience, and history of hazards
associated with its operations, using the recommendations provided in Chapter 2 of this
guidance in combination with the information provided in Chapter 3 of this guidance. Similarly,
section A1.7 recommends that each facility identify known or reasonably foreseeable
(“potential”) facility-related hazards for its products based on its knowledge, experience, and
history of hazards associated with its facility, using the recommendations provided in Chapter 2
of this guidance in combination with the information provided in Chapter 3 of this guidance.
Although Appendix 1 is comprehensive, it is not exhaustive and only reflects data and
information available as of 2022. New information about hazards that could be associated with
certain types of food products could become available in the future. In addition, Appendix 1
does not address specialty ingredients such as seaweed (other than seaweed extracts such as
carrageenan), proteins extracted from plants (e.g., protein extracted from peas), proteins
produced through microbial fermentation (e.g., egg-white protein produced through yeast
fermentation), and microorganisms (e.g., Bifidobacterium spp. and Lactobacillus spp.).
Information that you could use to evaluate known or reasonably foreseeable (“potential”)
hazards in such ingredients includes technical data sheets provided by the supplier, and
specifications that are established in the Food Chemicals Codex or an FDA regulation or that
are described in FDA’s response to a GRAS notice.
5
If you do not find readily available
information about known or reasonably foreseeable (“potential”) hazards in an ingredient, you
could check with the supplier of the ingredient.
While Appendix 1 is a comprehensive starting point, each facility has the ultimate responsibility
to identify the hazards relevant to food manufactured, processed, packed, or held at that facility,
such as hazards that are associated with its facility-specific history even though they are not
identified as known or reasonably foreseeable (“potential”) hazards in the tables.
A1.5 Organization of Appendix 1
A1.5.1 Food Groups Addressed by Appendix 1
We organized Appendix 1 around 16 Food Groups, identified as Food Groups A through P:
• Food Group A: Bakery Items
• Food Group B: Beverage items
• Food Group C: Food Additives, Color Additives, and GRAS Substances
• Food Group D: Chocolate and Candy
• Food Group E: Dairy
• Food Group F: Dressings, Condiments, and Dips
• Food Group G: Egg and Egg Products
• Food Group H: Fruits and Vegetables
• Food Group I: Game Meat Products
5
For information about GRAS notices and FDA’s response to GRAS notices, see our website (Table 8 in
section VI of the Introduction of this guidance).
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• Food Group J: Grains, Pulses, Flours, and Starches
• Food Group K: Nuts and Seeds
• Food Group L: Oils and Oil Products
• Food Group M: Snack Foods
• Food Group N: Soups and Sauces
• Food Group O: Spices and Herbs
• Food Group P: Food Sweeteners (Nutritive and Non-Nutritive)
A1.5.2 Tables of Known or Reasonably Foreseeable Hazards (“Potential
Hazards”)
We organized the information regarding known or reasonably foreseeable hazards (“potential
hazards”) in Appendix 1 as follows:
• Section A1.10 includes Tables 1A through 1P, which list the most relevant
6
food-related
biological hazards in Food Subcategories in the 16 Food Groups. These Tables are
marked (with an “X”) for those food-related biological hazards that SMEs recommended be
identified as known or reasonably foreseeable hazards (“potential hazards”) for subsequent
hazard evaluation by a facility that produces food products in those Food Subcategories to
determine which hazards require a preventive control, as appropriate to the facility and its
food products.
• Section A1.11, which lists the most relevant food-related chemical hazards, is organized
around the same 16 Food Groups as those addressed in section A.1.10.
o In 12 of these 16 Food Groups, Tables 2B, 2C, 2D, 2E, 2G, 2H, 2I, 2J, 2K, 2L, 2O,
and 2P list the most relevant food-related chemical hazards in Food Subcategories.
These Tables are marked (with an “X”) for the most relevant
7
food-related chemical
hazards that SMEs recommended be identified as known or reasonably foreseeable
hazards (“potential hazards”) for subsequent hazard evaluation by a facility that
produces food products in those Food Subcategories to determine which hazards
require a preventive control as appropriate to the facility and its food products.
o In four of these 16 Food Groups (i.e., Bakery Items; Dressings, Condiments, and Dips;
Snack Foods; and Soups and Sauces), the known or reasonably foreseeable
(“potential”) chemical hazards depend on the ingredients used. To maintain the overall
organization associated with the 16 Food Groups, section A1.11 includes an entry for
that Food Group (i.e., Food Groups 2A, 2F, 2M, and 2N) and recommends that you
refer to the Tables most applicable to the ingredients you use.
6
In determining the most relevant biological hazards to list in the Tables, we first selected 12 of the major
pathogens identified as being associated with foodborne illness in the United States. (Scallan et al.,
2011.) As discussed in section A1.6.1.2.2, we subsequently deleted Shigella spp. from the relevant
biological hazards listed in the Tables.
7
For information on factors that we considered in determining the most relevant chemical hazards to list
in the Tables, see section A1.6.2.
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For more information about the hazards in these Tables, see chapter 3 and section A1.6.
A1.5.3 Organization of Each Table in Appendix 1
Each Table in Appendix 1 represents one Food Group, which is identified in the title of the
Table. Below, we describe the elements of these Tables.
• Food Category: The main subdivision within each of the 16 individual Food Groups
• #: A code (with a number or a number/letter combination) assigned to each Food
Subcategory
• Food Subcategory: Descriptive details to distinguish food items within the Food Category.
See section A1.5.4 for more information about the Food Subcategories. The Food
Subcategories may not include “niche” food products, raw materials, or ingredients that
result from an evolution of food products over time.
• Storage Conditions: The Tables for most (but not all) Food Groups specify storage
conditions for Food Subcategories in that Food Group. For example, the Tables for Bakery
Items identify three storage conditions (e.g., refrigerated storage, frozen storage, and
ambient storage) that apply to specific subcategories of Bakery Items.
• Hazards: See Chapter 3 for detailed information about the hazards that are most relevant to
food safety. An “X” marks those hazards that SMEs recommended be identified as known or
reasonably foreseeable hazards ("potential hazards") for subsequent hazard evaluation by a
facility that produces food products in those Food Subcategories to determine whether these
are hazards that require a preventive control as appropriate to the facility and its food
products. For help in determining which of these recommendations apply to your food
product and might be hazards requiring a preventive control as appropriate to your facility
and your food, see Chapter 2 and Chapter 3 and the discussion in section A1.8.
• Comments: In general, your knowledge of your food product (e.g., ingredients, intended use,
and storage conditions) should enable you to identify the Food Category and Food
Subcategory that best represents it. However, although some products obviously fall into a
Food Category and Subcategory, others may not. For example, “chocolate chip cookies”
obviously fall into the Food Category Brownies/Cookies, but it may not be obvious that the
Tables consider biscotti to be a “cookie.” Therefore, the Comments provide examples of
products that may not obviously fall into a Food Category and Subcategory.
Importantly, the food products in a Food Subcategory, and the sources of food ingredients in the
Food Subcategories, are diverse. As a result, the recommendations of SMEs in the Tables in
Appendix 1 may not always apply to all food products in that Food Subcategory. See the
recommendations in section A1.8 regarding how to use the Tables in this Appendix, including
discussion that hazards that SMEs recommended be identified as known or reasonably
foreseeable hazards (“potential hazards”) might not apply to all food products in a Food
Subcategory; each facility determines, through its hazard analysis, those known or reasonably
foreseeable hazards (“potential hazards”) that require a preventive control.
Food products evolve and, thus, over time there will be food products that are not addressed in
the Tables of potential hazards. If you identify a Food Subcategory that has characteristics of
your food product, you may still be able to use the Tables in Appendix 1 to help you identify
known or reasonably foreseeable hazards (“potential hazards”) that warrant evaluation to
determine whether they are hazards requiring a preventive control for your food product.
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A1.5.4 The Food Subcategories in the Tables in Appendix 1 Address Raw
Materials, Other Ingredients, and Multi-Component Foods
Most foods contain multiple raw materials and other ingredients. Although many of the foods in
the Tables are multi-component foods, it is not practical to include all multi-component foods in
the tables, because the ingredients and processing methods can vary widely (e.g., entrées, side
dishes, sandwiches). To assess the biological and chemical hazards for these multi-component
foods, you should consider the hazards associated with the individual raw materials/ingredients,
as well as the hazards that may arise from the processing methods used in making them.
Some Tables, such as the “Food Additives, Color Additives, and GRAS Substances” Food
Group Table, address food materials that are almost exclusively used as ingredients in the
production of other foods. Examples of foods in the “Food Additives, Color Additives, and GRAS
Substances” Food Group are emulsifiers, stabilizers and thickeners, enzymes, colors, flavors,
and other ingredients (such as antimicrobials and preservatives).
Other Tables address Food Groups with Food Categories and Food Subcategories that are
both commonly used as raw materials or other ingredients in the production of multi-
component foods and commonly consumed as finished foods. When using these Tables, the
known or reasonably foreseeable hazards (“potential hazards”) that you should consider for an
ingredient that you use in manufacturing/processing one of these food products could depend
on how you use the ingredient. For example:
• Food products that are in the “Whole, Grains” Food Subcategory in Table 1J (e.g., barley,
quinoa) are commonly sold both to manufacturers/processors for use as an ingredient in
multi-component foods and to consumers. Multi-component foods manufactured/processed
using whole grains as an ingredient can be dry foods (such as dry mixes that consumers
use in cooking) or high-moisture foods (such as cooked grain bowls and cooked grain-based
side dishes) in which the whole grains are hydrated during manufacturing/processing. You
should consider Bacillus cereus as a known or reasonably foreseeable hazard (“potential
hazard”) when you use the whole grains to manufacture/process a cooked high-moisture
product (where B. cereus could grow), but not when you distribute dry whole grains to
consumers or use the dry whole grains to manufacture/process a dry mix that consumers
will cook.
• Food products that are in the “Dry Mixes, Powders” Food Subcategory in the “Soups,
Sauces, Gravies” Food Category in Table 1N are commonly sold both to
manufacturers/processors for use as an ingredient in multi-component foods (such as
refrigerated or frozen meals) and to consumers (e.g., for use in an entrée prepared at home
by rehydration followed by cooking). You should consider pathogenic sporeformers such as
B. cereus and C. perfringens as known or reasonably foreseeable hazards (“potential
hazards”) when you use a dry mix or powder as an ingredient of a sauce that you use to
manufacture/process a frozen meal, but not when you use the dry mix or powder to
manufacture/process a dry sauce mix packaged for retail sale to consumers.
• Food products that are in the “Dried, Ground, Cracked, or Whole” Food Subcategory in the
“Spices” Food Category in Table 1O are commonly sold both to manufacturers/processors
for use as an ingredient in multi-component foods (such as high-moisture dips, sauces, and
refrigerated and frozen meals) and to consumers (e.g., for use in an entrée prepared at
home). You should consider pathogenic sporeformers such as B. cereus and C. perfringens
as known or reasonably foreseeable hazards (“potential hazards”) when you use a product
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in this Food Subcategory to manufacture/process high-moisture foods such as dips, sauces,
and refrigerated and frozen meals (where high moisture could allow growth of pathogenic
sporeformers), but not when you use a dry product in this Food Subcategory to
manufacture/process a dry spice mix.
Some Food Categories and Food Subcategories could apply to more than one Table. For
example, oil-based flavor extracts from plants appear in the oil-based liquid Subcategory of the
Flavor Category in Table 1C (Miscellaneous Food Additives, Color Additives, and GRAS
Substances) as well as in the essential oil Subcategory in the Seasonings Category in Table 1O
(Spices and Herbs). As another example, the category/subcategory of dairy-based ready-to-
drink beverages appear in Table 1B (Beverage Items) as well as in the cultured milk products
subcategory of the milk and butter category in Table 1E (Dairy Products).
A1.5.5 Food Categories/Food Subcategories that Are LACF
The PCHF requirements do not apply with respect to activities that are subject to the LACF
regulations (21 CFR part 113) for the control of biological hazards and, thus, LACF foods are
not covered by the Food Categories/Food Subcategories in Tables 1A through 1P (Food-
Related Biological Hazards). (See 21 CFR 117.5(d).) C. botulinum would be the biological
hazard associated with an LACF used as an ingredient; the hazard would be controlled by the
supplier.
The PCHF requirements do apply to chemical and physical hazards that could be associated
with an LACF food. The Tables in section A1.11 address chemical hazards that you should
consider for LACF. For example, for the known or reasonably foreseeable (“potential”) chemical
hazards associated with a canned vegetable, you should look at Table 2H, which addresses the
Food Group Fruits and Vegetables.
A1.5.6 Infant Formula and Other Foods for Infants and Toddlers
Infant formula is a specialized, multi-component food. The Food Categories/Food Subcategories
in the Tables in Appendix 1 do not list infant formula. When you manufacture/process an infant
formula, you should consider whether there are known or reasonably foreseeable biological or
chemical hazards (“potential biological or chemical hazards”) associated with the ingredients of
that infant formula.
The Food Categories/Food Subcategories in the Tables in Appendix 1 do not specifically
identify “baby food,” such as pureed fruits and vegetables intended for consumption by infants
and toddlers. When you manufacture/process a food intended for consumption by infants or
toddlers, you should look for a broader term applicable to that food. For example, for “baby
food” that contains fruit, you could look at the Heat-Treated Fruit Products Subcategory or any
of the other fruit-related Subcategories in Tables 1H and 2H. For “baby food” that contains a
vegetable, you could look at any of the vegetable-related Subcategories in Tables 1H and 2H.
See also the discussion of known or reasonably foreseeable (“potential”) biological hazards in
infant formula and other foods for infants and toddlers in section A1.6.1.5 and the discussion of
known or reasonably foreseeable (“potential”) chemical hazards in infant formula and other
foods for infants and toddlers in section A1.6.2.5.
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A1.6 Tables of Known or Reasonably Foreseeable Hazards (“Potential
Hazards”) in Appendix 1
A1.6.1 Food-Related Biological Hazards
A1.6.1.1 The most relevant food-related biological hazards
Chapter 3 of this guidance provides background information (e.g., characteristics of
microorganisms that can contaminate food and potential sources of these microbial
contaminants) for the following food-related biological hazards that are most relevant to food
safety:
• Bacillus cereus
• Clostridium botulinum
• Clostridium perfringens
• Brucella spp.
• Campylobacter spp.
• Pathogenic E. coli
• Salmonella spp.
• Listeria monocytogenes
• Shigella spp.
• Staphylococcus aureus
• Parasites
• Viruses
As discussed in section A1.3, Chapter 3 does not provide an exhaustive compendium of
biological, chemical, and physical hazards. Likewise, Tables 1A through 1P do not include an
exhaustive list of known or reasonably foreseeable (“potential”) biological hazards. For example,
Tables 1A through 1P do not list the biological hazard Cronobacter spp. (including C. sakazakii)
because Cronobacter spp. (including C. sakazakii) is largely a hazard for powdered infant
formula rather than a hazard applicable to foods for the general population.
8
However, Table 1E
(for the Food Category Dairy) notes that the SMEs recommend considering Cronobacter spp.
(including C. sakazakii) as a known or reasonably foreseeable (“potential”) biological hazard in
powdered milk intended for use in infant formula.
Many RACS that are raw materials or ingredients in food products could be contaminated with
multiple known or reasonably foreseeable (“potential”) biological hazards. In many cases,
processing to control the most common of these known or reasonably foreseeable (“potential”)
biological hazards for a Food Subcategory would also control biological hazards that are less
common. For example, the most common known or reasonably foreseeable (“potential”)
8
The draft Chapter 3 that we made available for public comment in 2016 did not discuss Cronobacter
spp. When we finalize that chapter, we intend to add a discussion of Cronobacter spp. and applicable
references.
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biological hazard for raw cocoa beans is Salmonella. Processing to control Salmonella would
also control less common known or reasonably foreseeable (“potential”) biological hazards for
raw cocoa beans (such as L. monocytogenes and pathogenic E. coli). Therefore, Table 1D only
identifies Salmonella as a known or reasonably foreseeable (“potential”) biological hazard for
raw cocoa beans.
A1.6.1.2 Note about viruses, parasites, and Shigella spp.
In food establishments subject to part 117, contamination of food with biological hazards that
are viruses (e.g., norovirus and hepatitis A virus), parasites (e.g., Cryptosporidium spp.,
Cyclospora cayetanensis, and Giardia intestinalis) or the bacterial pathogen Shigella spp. by
food handlers generally is addressed by following the CGMPs such as those relevant to worker
hygiene and disease control. (See 21 CFR 117.10.) Likewise, when an entity that supplies
produce to a food facility for use as an ingredient in a food product is subject to our produce
safety regulation entitled “Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption” (21 CFR part 112), that supplier addresses biological
hazards that are viruses, parasites, or Shigella spp. by following provisions such as the
standards for Health and Hygiene in part 112, subpart D. For waterborne viruses and parasites
and for Shigella spp. (which can be present due to fecal contamination), a supplier of produce
that is subject to 21 CFR part 112 would also follow the standards for Agricultural Water in part
112, subpart E
9
.
A1.6.1.2.1 Viruses and parasites
There are very few Food Subcategories in which the SMEs identified viruses or parasites as
known or reasonably foreseeable (“potential”) biological hazards for subsequent hazard
evaluation to determine whether they are hazards requiring a preventive control. In the “Fruits
and Vegetables” Food Group (see Table 1H), these Food Subcategories are:
• “Whole RAC” Food Subcategory in the “Fruits” Food Category;
• “Fresh-cut” Food Subcategory in the “Processed Fruits” Food Category;
• “Whole or Cut” (Frozen) Food Subcategory in the “Processed Fruits” Food Category; and
• “Whole RAC” Food Subcategory in the “Vegetables” Food Category.
Note that footnotes in Table 1H identify specific foods for which the SMEs identified viruses or
parasites as known or reasonably foreseeable (“potential”) biological hazards for subsequent
hazard evaluation within the Food Category.
In the “Game Meat” Food Group (see Table 1I), the SMEs identified the parasite Toxoplasma
gondii as associated with wild boar, deer and elk and considered that Trichinella spp. is
primarily a problem with wild game such as wild boar, bear and walrus. This guidance does not
address hazards associated with wild game meat, only farm-raised game meat. Thus, Table 1I
9
In 2019, FDA extended the dates for compliance with the provisions of part 112, subpart E for covered
produce other than sprouts (84 FR 9706, March 18, 2019). The compliance dates range from January 26,
2022, through January 26, 2024, depending on the size of a covered farm. In 2021, FDA proposed to
amend the agricultural water provisions of the produce safety regulation that covered farms have found
complex and challenging to implement (86 FR 69120, December 6, 2021). In that proposed rule, FDA
announced its intent to exercise enforcement discretion for these subpart E requirements while pursuing
a targeted compliance date rulemaking, with the goal of completing the rulemaking as quickly as possible.
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only identifies Toxoplasma gondii as a known or reasonably foreseeable (“potential”) biological
hazard for deer and elk that are farmed for commercial meat distribution.
A1.6.1.2.2 Shigella spp.
Outbreaks of foodborne shigellosis have been associated with contaminated raw vegetables
such as lettuce salads, shredded cabbage, green onions and parsley (Beuchat, 1996; Long et
al., 2002; Naimi et al., 2003), and the SMEs identified Shigella spp. as known or reasonably
foreseeable (“potential”) biological hazards for subsequent hazard evaluation for these raw
vegetables in the “Fruits and Vegetables” Food Group. The SMEs also identified Salmonella
and/or pathogenic E. coli as known or reasonably foreseeable (“potential”) biological hazards for
these raw vegetables in the “Fruits and Vegetables” Food Group. If you identify Salmonella
and/or pathogenic E. coli as a hazard requiring a preventive control, a preventive control that
you establish and implement to significantly minimize or prevent Salmonella or pathogenic E.
coli generally would also significantly minimize or prevent Shigella spp. Therefore, we decided
that it was not necessary to separately identify Shigella spp. as a known or reasonably
foreseeable (“potential”) biological hazard for subsequent hazard evaluation in any Food
Group, and none of the Tables in section A1.10 list Shigella spp. as a known or reasonably
foreseeable (“potential”) biological hazard.
A1.6.1.3 Note about biological hazards in food subcategories manufactured
using exceptionally lethal processes
Some food products can only be produced using exceptionally lethal processes that adequately
control biological hazards. If the processing is not conducted in a way that adequately controls
biological hazards, the product would not be suitable for distribution. Due to the exceptional
lethality of the processes used to manufacture these food products, in some instances the
SMEs did not identify any known or reasonably foreseeable (“potential”) biological hazards for
these foods (e.g., sugar confections in Table 1D and crackers in Table 1M). In other instances,
the tables indicate known or reasonably foreseeable (“potential”) biological hazards, but a
facility could determine these are not hazards requiring a preventive control because they are
produced using an exceptionally lethal process (e.g., soups, sauces and gravies, where some of
the products receive an exceptionally lethal process but other products do not).
For example:
• A process of making caramel by boiling ingredients such as sugar, butter, and sweetened
condensed milk for several minutes to about 240
o
F (116
o
C) would provide exceptional
lethality for biological hazards (e.g., Listeria monocytogenes); without boiling for several
minutes, the ingredients will not result in a chewy caramel when cooled. Thus, the SMEs did
not identify any known or reasonably foreseeable (“potential”) biological hazards associated
with the “Sugar Confections” Food Subcategory (e.g., caramels) in the “Chocolate and
Confectionery Products” Food Category (Table 1D).
• A process of making jam, jelly, or chutney by a process that includes boiling would provide
exceptional lethality for biological hazards (e.g., pathogenic E. coli, Salmonella species
(spp.), and Listeria monocytogenes); without boiling these products will not thicken to the
desired consistency. Thus, the SMEs did not identify any known or reasonably foreseeable
(“potential”) biological hazards associated with the “Jams, Jellies, Chutneys” Food
Subcategory in the “Processed Fruits” Food Category (Table 1H).
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• A process of making a shelf-stable acid or acidified fruit cocktail would provide exceptional
lethality for biological hazards (e.g., pathogenic E. coli, Salmonella spp., and Listeria
monocytogenes). The process for making the fruit cocktail that can be stored at ambient
temperatures is designed to inactivate certain non-pathogenic sporeformers that could
cause spoilage; these sporeformers have much greater heat resistance than the vegetative
pathogens that are the biological hazards in the ingredients. The SMEs identified several
known or reasonably foreseeable (“potential”) biological hazards associated with the
Subcategory “Heat-Treated Fruit Products” in the “Processed Fruits” Food Category (Table
1H) but noted that some of these foods may receive an exceptionally lethal process.
• A process of making a gravy by boiling or cooking down a liquid sauce to thicken it would
provide exceptional lethality for vegetative pathogens such as E. coli O157:H7, Salmonella
spp. and Listeria monocytogenes, and, if one of these is the pertinent pathogen in an
ingredient, you may not need to consider it as a known or reasonably foreseeable
(“potential”) biological hazard. (Alternatively, your PCQI could identify vegetative pathogens
such as E. coli O157:H7, Salmonella spp. or Listeria monocytogenes, as known or
reasonably foreseeable (“potential”) biological hazards for ingredients used in making gravy,
but determine that they do not require a preventive control because the process is
exceptionally lethal.) The SMEs identified several known or reasonably foreseeable
(“potential”) biological hazards associated with the Subcategories in the “Soups, Sauces,
Gravies” Food Category (Table 1N) but noted that some of these foods may receive an
exceptionally lethal process.
• A baking process (e.g., 482
o
F (250
o
C) for 4.5 min.) used in the manufacture of snack
crackers would provide exceptional lethality for vegetative pathogens such as E.
coli O157:H7, Salmonella spp. and Listeria monocytogenes; without this high temperature
process, the baked and cooled product would not have or retain the characteristic texture
desired for this snack item. Thus, the SMEs did not identify any known or reasonably
foreseeable (“potential”) biological hazards associated with the “Baked, Unfilled,
Unseasoned or Seasoned” Food Subcategory in the “Crackers” Food Category (Table 1M).
A1.6.1.4 Note about biological hazards in products produced in
establishments that are under the jurisdiction of USDA
The production of certain meat products (but not game meat products), poultry products, and
processed egg products (e.g., pasteurized liquid whole egg) is subject to regulation by USDA’s
FSIS under the statutes it administers (i.e., the Federal Meat Inspection Act (21 U.S.C. 601 et
seq.), the Poultry Products Inspection Act (21 U.S.C 451 et seq.), and the Egg Products
Inspection Act (21 U.S.C. 1031 et seq.). None of the Food Groups in Appendix 1 is directed to
products while under the sole jurisdiction of USDA’s FSIS. However, some FSIS-regulated
products are sometimes used as ingredients in food products that are subject to our regulation
under the FD&C Act and produced in accordance with the requirements of part 117. For
example, in the Food Group “Egg and Egg Products” the Food Category “Further Processed
Egg Products” subcategory “Cooked Egg Products” includes products such as egg patties
(which can be an ingredient in breakfast sandwiches) that can be made with liquid whole egg,
an FSIS-regulated food. If you use a food product that is produced under the jurisdiction of
USDA’s FSIS as an ingredient in your food product, you should determine, through your hazard
analysis, whether a hazard you identify as a known or reasonably foreseeable (“potential”)
biological hazard in that ingredient is a hazard requiring a preventive control.
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In the Federal Register of October 29, 2020 (85 FR 68640), FSIS published a final rule to apply
the egg products regulations to egg substitutes (e.g., egg whites) and freeze-dried products
(e.g., freeze-dried breakfast items for outdoor recreation) and require inspection of these
products. The final rule is effective October 30, 2023. The Food Group “Egg and Egg Products”
no longer includes egg substitutes and freeze-dried products.
A1.6.1.5 Note about biological hazards in infant formula and other foods for
infants and toddlers
As discussed in section A1.5.6, the Food Categories/Food Subcategories in the Tables in
Appendix 1 do not list infant formula or other foods for infants or toddlers. When you
manufacture/process an infant formula or other food for infants or toddlers, you should consider
whether there are known or reasonably foreseeable (“potential”) biological hazards associated
with the ingredients in that infant formula or other food for infants and toddlers.
Importantly, the controls to prevent adulteration from microorganisms in our infant formula
regulations in 21 CFR part 106
10
specify criteria for when a powdered infant formula that
contains Cronobacter spp. or Salmonella spp. will be deemed adulterated under sections
402(a)(1), 402(a)(4), and 412(a)(3) of the FD&C Act. You must comply with these
microbiological criteria when you manufacture/process powdered infant formula. (See 21 CFR
106.55(e).)
A1.6.1.6 Note about biological hazards in food products produced using
ingredients that are pasteurized or otherwise treated to control biological
hazards
Many biological hazards that could be in ingredients are controlled by pasteurization or other
treatment that is performed by the supplier of those ingredients. For example, in many
circumstances your supplier would control known or reasonably foreseeable (“potential”)
biological hazards in milk-based ingredients used to make products such as dairy-based
beverages, cream, cultured milk products, and cheese, or in egg-based ingredients used to
make products such as some condiments. Tables 1A through 1P list the known or reasonably
foreseeable (“potential”) biological hazards that could be in a food product due to the ingredients
in the food product regardless of whether the outcome of the hazard analysis is that a hazard
that requires a preventive control is controlled by you (e.g., by a process control) or by your
supplier.
A1.6.1.7 Note about biological hazards in food products that consumers
cook
In some cases, the outcome of your hazard analysis for foods such as uncooked fruit pies could
be that known or reasonably foreseeable (“potential”) biological hazards will be controlled by
consumer cooking rather than by a preventive control.
10
Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control
Procedures, Quality Factors, Records and Reports, and Notifications
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A1.6.2 Food-Related Chemical Hazards
A1.6.2.1 The most relevant food-related chemical hazards
Chapter 3 of this guidance provides background information
11
(e.g., characteristics of chemicals
that can contaminate food and potential sources of these chemical contaminants) for the
following food-related chemical hazards that are most relevant to food safety:
• drug residues in milk, honey, and game meat;
• environmental contaminants (e.g., dioxins and PCBs);
• food allergens and substances associated with a food intolerance or food-related disease
(e.g., sulfites, gluten);
• toxic elements
12
in or on produce ingredients;
• mycotoxins
13
in commodities such as grains, apples, peanuts, and tree nuts;
• natural toxins (such as hypoglycin A in ackee and cyanogenic glycosides in cassava
(yuca)
14
);
• pesticides in or on produce RACs
15
;
• radiological hazards; and
• unapproved food or color additives.
The Tables in section A1.11 address drug residues, toxic elements, mycotoxins/natural toxins,
and pesticides. As discussed in sections A1.6.2.2 through A1.6.2.4, these Tables do not
11
A reference that we did not include in draft Chapter 3 of this guidance is the European Union's Rapid
Alert System for Food and Feed (RASFF) (Table 8 in section VI of the Introduction of this guidance).
RASFF enables information to be shared efficiently between its members when risks to public health are
detected in the food chain. The RASFF portal features an interactive searchable online database. It gives
public access to summary information about the most recently transmitted RASFF notifications as well as
the ability to search for information on any notification issued in the past. When we finalize Chapter 3, we
intend to identify RASFF as a resource for you to use in determining whether a chemical hazard is a
known or reasonably foreseeable (“potential”) hazard requiring a preventive control.
12
The discussion in the draft Chapter 3 that we made available for public comment in 2016 focused on
the toxic elements that are heavy metals. When we finalize that chapter, we intend to discuss toxic
elements more broadly, consistent with the discussions of toxic elements in FDA’s “Closer to Zero” action
plan (Table 8 in section VI of the Introduction of this guidance). Import Alert 99-42 (Table 5 in section VI
of the Introduction of this guidance) covers specific firms that have offered foods with levels of heavy
metals that may render a product injurious to health and that may be detained without physical
examination in accordance with the guidance in FDA's Regulatory Procedures Manual Chapter 9-8 (Table
8 in section VI of the Introduction of this guidance).
13
FDA’s Import Alert 23-14 identifies mycotoxins associated with certain food types (Table 5 in section VI
of the Introduction of this guidance).
14
The draft Chapter 3 that we made available for public comment in 2016 did not identify cyanogenic
glycosides as a natural toxin. When we finalize that chapter, we intend to include cyanogenic glycosides
as a natural toxin.
15
See Liang et al., 2021 and FDA’s Pesticide Residue Monitoring Program Reports and Data for
commodities associated with pesticides (Table 8 in section VI of the Introduction of this guidance).
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address food allergens, substances associated with a food intolerance or food-related disease,
radiological hazards, dioxins, and unapproved food or color additives.
As discussed in Chapter 3, the PCHF requirements specify that you must consider, as part of
your hazard identification, known or reasonably foreseeable hazards that may be intentionally
introduced for purposes of economic gain (21 CFR 117.130(b)(2)(iii)) and recommends that you
focus on circumstances where there has been a pattern of such adulteration in the past.
Chapter 3 includes a quick reference guide (Table 3-8) that lists circumstances where there has
been a pattern of such adulteration in the past and identifies additional resources that you can
use for this purpose. The Tables in section A1.11 do not further address known or reasonably
foreseeable hazards that may be intentionally introduced for purposes of economic gain.
A1.6.2.2 Note about food allergen hazards and substances associated with
a food intolerance or food-related disease
See the discussion of food allergen hazards in Chapter 3.
16
The Food Allergen Labeling and
Consumer Protection Act of 2004 (FALCPA) amended the FD&C Act and defined the following
eight foods and any ingredients that contain protein derived from these eight foods (with certain
exemptions noted in section 201(qq)(2) of the FD&C Act (21 U.S.C. 321(qq)(2)), including highly
refined oils) as major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts,
wheat, and soybeans. In 2021, the Food Allergy Safety, Treatment, Education, and Research
Act of 2021 (FASTER) amended the definition of "major food allergen" to add sesame to that
definition, effective for food that is introduced or delivered for introduction into interstate
commerce on or after January 1, 2023.
A food allergen hazard can occur due to an undeclared food allergen in your food product or in
raw materials or other ingredients that you receive from a supplier. A food allergen hazard also
can occur due to unintended allergen presence
17
that can occur during production of your food
product or during production of raw materials or other ingredients that you receive from a
supplier. As a result, a food allergen hazard could be identified as a known or reasonably
foreseeable (“potential”) chemical hazard for a majority of food products. Rather than identifying
food allergen hazards as known or reasonably foreseeable (“potential”) chemical hazards for
most food subcategories, the Tables of food-related chemical hazards do not address food
allergen hazards.
As discussed in Chapter 3, for some consumers, certain substances can cause hypersensitivity
reactions. Like food allergens, these substances are lawfully used in food. Also, like food
allergens, some of these substances are subject to labeling requirements. For example, some
sulfiting agents must be listed on the ingredient label unless they are added to food as an
“incidental substance”; sulfiting agents are considered to be incidental only if they have no
technical effect in the finished food and are present at less than 10 parts per million (ppm) (21
CFR 101.100(a)(4)). Because such substances generally are intentionally added to food (rather
than be contaminants that could be unintentionally added to food), the Tables of food-related
chemical hazards do not address these substances.
16
For information on controlling food allergen hazards, see Chapter 11 of this guidance.
17
We use the term “unintended allergen presence” to mean the presence of an allergen due to allergen
cross-contact.
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A1.6.2.3 Note about radiological hazards, dioxins, PCBs, and toxic
elements
See the discussion of radiological hazards in Chapter 3. Radiological hazards rarely occur in the
food supply. There are two primary sources of radiological hazards:
• water: the primary source of water that could be contaminated with radiological hazards is
well water in specific areas in the United States where high concentrations of some
radionuclides, such as radium-226, radium-228, and uranium, have been detected in well
water; and
• accidental contamination, e.g., contamination arising from accidental release from a nuclear
facility or from damage to a nuclear facility from a natural disaster.
Radiological hazards that result from contaminated well water or from accidental contamination
can affect almost any Food Subcategory. Rather than identify radiological hazards as known or
reasonably foreseeable (“potential”) chemical hazards for all food subcategories, the Tables of
food-related chemical hazards do not address radiological hazards. We recommend that you
consider the information in Chapter 3 regarding radiological hazards when conducting your
hazard analysis for your food products.
See also the discussion of dioxins and PCBs, which are environmental contaminants
18
, in
Chapter 3. Because dioxins and PCBs rarely occur in the food supply and are largely
associated with accidental contamination, the Tables of food-related chemical hazards do not
address dioxins or PCBs.
Table 3-1 in Chapter 3 identifies four heavy metals (which we now refer to as “toxic elements”)
as chemical hazards that can contaminate food: arsenic, cadmium, lead, and mercury. This
Appendix does not address mercury, which is principally a hazard in seafood products that are
not covered by this guidance.
Water is an ingredient in many food products. If you source a water-containing food from a
geographic area in which water has been contaminated with toxic elements, you may need to
consider whether a toxic element is a known or reasonably foreseeable (“potential”) hazard for
your food product (Keurig Dr Pepper, 2019; see also FDA Import Alert 99-42 in Table 5 in
section VI of the Introduction of this guidance).
A1.6.2.4 Note about unapproved food and color additives
See the discussion of food additives, color additives, and GRAS substances in Chapter 3,
including the statutory framework applicable to substances that are added to food. An
unapproved food or color additive that results from use of a substance that is not lawful for use
in food can affect almost any Food Subcategory. Rather than identify unapproved food or color
additives as known or reasonably foreseeable (“potential”) chemical hazards for all food
18
The draft Chapter 3 that we made available for public comment in 2016 did not discuss perchlorates
and per- and polyfluoroalkyl substances (PFAS), which can result from industrial contamination. When we
finalize that chapter, we intend to include perchlorates and PFAS as examples of environmental
contaminants.
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subcategories, the Tables of food-related chemical hazards do not address unapproved food
and color additive hazards.
A substance that is GRAS under the conditions of its intended use is not subject to the
premarket review and approval requirements applicable to food and color additives. Although
some GRAS substances are listed in our regulations, other GRAS substances are lawfully used
in food without being listed in our regulations.
Some food and color additives are specifically prohibited from use in food because we have
determined that the chemical additive poses a potential risk to public health (see 21 CFR part
189 and 21 CFR 81.10). Examples of such food and color additives are coumarin (21 CFR
189.130), safrole (21 CFR 189.180), and FD&C Red No. 4 (“Red No. 4”) (21 CFR 81.10(d)). We
consider a prohibited food additive or color additive to be an unapproved food additive or color
additive for the purposes of the PCHF requirements and, thus, to be a chemical hazard.
We recommend that you consider the information in Chapter 3 to reduce the potential for an
unapproved food or color additive in your food products. We intend to update Chapter 3 to
highlight the following resources:
• Food and color additive regulations. The most relevant regulations are in:
o 21 CFR part 73: Listing of Color Additives Exempt from Certification
o 21 CFR part 74: Listing of Color Additives Subject to Certification
o 21 CFR part 172: Food Additives Permitted for Direct Addition to Food for Human
Consumption
o 21 CFR part 173: Secondary Direct Food Additives Permitted in Food for Human
Consumption
• The Color Additive Status List and the Food Additive Status List (Table 8 in section VI of the
Introduction of this guidance)
• Lists of substances that are used in food under the GRAS provisions of the FD&C Act,
including:
o 21 CFR part 182: Substances Generally Recognized as Safe
o 21 CFR part 184: Direct Food Substances Affirmed as Generally Recognized as Safe
o GRAS Notice Inventory (Table 8 in section VI of the Introduction of this guidance)
A1.6.2.5 Note about toxic element hazards in foods for infants and toddlers,
including infant formula
As discussed in section A1.5.6, the Food Categories/Food Subcategories in the Tables in
Appendix 1 do not list infant formula or other foods for infants and toddlers. When you
manufacture/process an infant formula or other food for infants or toddlers, you should consider
whether there are known or reasonably foreseeable (“potential”) chemical hazards associated
with the ingredients in that infant formula or other food for infants or toddlers.
FDA’s “Closer to Zero” action plan (Table 8 in section VI of the Introduction of this guidance)
identifies actions we will take to reduce exposure to toxic elements from foods eaten by babies
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and young children. We have prioritized babies and young children because their smaller body
sizes and metabolism make them more vulnerable to the harmful effects of these contaminants.
The “Closer to Zero” action plan follows a four-stage iterative approach that includes research,
regulatory, and outreach efforts to lead to the development of action levels for certain toxic
elements in categories of baby foods (e.g., cereals, pureed fruits and vegetables) and other
foods commonly eaten by babies and young children.
This guidance does not identify specific action levels for any toxic element hazards in foods for
infants and toddlers. Instead, we identify action levels or other recommendations for reducing
toxic elements in foods for infants and toddlers in more specific guidance such as Compliance
Policy Guides (Table 3 in section VI of the Introduction of this guidance) and Guidance for
Industry (Table 4 in section VI of the Introduction of this guidance). For example, as of the date
of publication of this Appendix, our Guidance for Industry addresses arsenic in rice cereal,
arsenic in juice, lead in juice, lead in food intended for babies and young children, and lead in
candy likely to be consumed frequently by small children (Table 4 in section VI of the
Introduction of this guidance). You should check our "Closer to Zero: Action Plan for Baby
Foods” website (Table 8 in section VI of the Introduction of this guidance), and our websites
listing Compliance Policy Guides and Guidance for Industry, for such action levels on a regular
basis, because the action plan’s iterative approach can lead to adjustments in any announced
action levels on an ongoing basis.
A1.6.2.6 Note about mycotoxin hazards
As discussed in Chapter 3 and in our Compliance Program
19
7307.001 (Mycotoxins in Domestic
and Imported Foods) (Table 5 in section VI of the Introduction of this guidance), mycotoxins are
a common group of natural toxins that include aflatoxin, fumonisin, deoxynivalenol (vomitoxin),
ochratoxin, and patulin. Mycotoxins are toxic metabolites produced by certain fungi (i.e., molds)
that can infect and proliferate on agricultural commodities (e.g., grains such as wheat and corn,
peanuts, fruits, and tree nuts) in the field and during storage. Specific mycotoxins are most
commonly associated with certain commodities as follows:
• aflatoxin: peanuts, dried corn, tree nuts, and some edible seeds
20
(melon seeds, pumpkin
seeds, and sunflower seeds);
• ochratoxin: cocoa, coffee, raisins, dried figs, cereal grains;
• fumonisins: dried corn;
• deoxynivalenol (vomitoxin): wheat, barley; and
• patulin: apples
19
FDA's Compliance Programs (Table 5 in section VI of the Introduction of this guidance) provide
instructions to FDA personnel for conducting activities to evaluate industry compliance with the FD&C Act
and other laws administered by FDA. Compliance Programs are made available to the public under the
Freedom of Information Act.
20
The draft Chapter 3 that we made available for public comment in 2016 did not discuss aflatoxins in
edible seeds. When we finalize that chapter, we intend to reference the information in our Compliance
Program 7307.001 (Mycotoxins in Domestic and Imported Foods; Table 5 in section VI of the Introduction
of this guidance).
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When a Table of known or reasonably foreseeable (“potential”) chemical hazards broadly
identifies the chemical hazard “mycotoxin,” a footnote in the Table also identifies the applicable
mycotoxin.
A1.7 Process-related Hazards and Facility-related Hazards
As discussed in Chapter 2 of this guidance, when conducting your hazard analysis, you
consider those known or reasonably foreseeable hazards (“potential hazards”) originating from
processes (process-related hazards), and the food-production environment (facility-related
hazards) (21 CFR 117.130(c)(2)). Because each facility is unique in its products, operations,
processes, and physical plant, process-related hazards and facility-related hazards can be
specific to each facility. Therefore, this Appendix 1 does not identify known or reasonably
foreseeable (“potential”) process-related hazards or facility-related hazards. Instead, we
recommend that each facility identify known or reasonably foreseeable (“potential”) process-
related hazards or facility-related hazards for its products based on its knowledge, experience,
and history of hazards associated with its operations. The recommendations provided in
Chapter 2 of this guidance and the information provided in Chapter 3 of this guidance are
resources for facilities to do so. For your convenience, we list the most relevant biological,
chemical, and physical hazards that are process-related or facility-related (as discussed in
Chapter 3) in sections A1.7.1 and A1.7.2.
For examples of known or reasonably foreseeable (“potential”) process-related hazards and
facility-related hazards that could be associated with certain operations, see sections A1.7.1
through A1.7.3.
A1.7.1 The Most Relevant Process-related and Facility-related Biological
Hazards
Sections 3.3.4 and 3.3.5 in Chapter 3 of this guidance provide background information for the
following process-related and facility-related biological hazards that are most relevant to food
safety:
• Bacterial Pathogens – Presence / growth / toxin production due to survival of a lethal
treatment. (Section 3.3.4.1)
o For example, a heat treatment that is not properly delivered (e.g., the temperature is too
low, or the heating time is insufficient) could allow a pathogen to survive; in some cases,
the surviving pathogens could subsequently grow and produce toxin.
• Bacterial Pathogens - Growth and/or toxin production due to poor time/temperature control.
(Sections 3.3.4.2.1 and 3.3.4.2.2)
o For example, a cooling mechanism that does not function as intended could allow a
small number of microbial pathogens to increase in number.
• Bacterial Pathogens - Growth and/or toxin production due to poor formulation control.
(Section 3.3.4.2.3)
o For example, if insufficient acid is added to reduce the pH sufficiently in an acidified
food, pathogenic sporeformers could grow and produce toxin.
• Bacterial Pathogens - Growth and/or toxin production due to reduced oxygen packaging
(ROP). (Section 3.3.4.2.4)
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o For example, reduced oxygen packaging that is used to increase shelf life could create
an environment that supports the growth of C. botulinum.
• Bacterial pathogens - Presence due to ingredients added after process controls. (Section
3.3.4.3)
• Bacterial Pathogens – Presence, growth, or growth with toxin production due to
recontamination due to lack of container integrity. (Section 3.3.4.4)
o For example, if a container is not properly sealed and it is cooled in water, water
containing pathogens can be drawn into the container.
• Environmental Pathogens – Presence due to recontamination from the processing
environment. (Section 3.3.5.1)
o For example, equipment that is difficult to clean or is prone to damage could increase
the risk for environmental pathogens to contaminate the product post-processing.
o As another example, facility traffic patterns can transfer environmental pathogens from
one process area to another.
See also Chapters 6 through 10 of this guidance. These chapters address process controls that
are heat treatments, time/temperature controls, formulation, drying/dehydrating, and sanitation
controls, respectively, applicable to process-related and facility-related biological hazards that
require a preventive control.
A1.7.2 The Most Relevant Process-related Chemical Hazards
Section 3.4.2 in Chapter 3 of this guidance provides background information for the following
process-related chemical hazards that are most relevant to food safety:
• Undeclared food allergens – Incorrect label (Sections 3.4.2.1.2 and 3.4.2.1.3). For example:
o An incorrect label can result if you change the product formulation to include a food
allergen but do not update the product label to declare that food allergen.
o If the product label is pre-printed on the product package, an incorrect label can result if
the wrong packaging is brought to the production line.
o If you apply the product label to the package after the package has been filled, an
incorrect label can result if the wrong label is brought to the production line.
• Unintended food allergen presence – allergen cross-contact (Section 3.4.2.1.4). For
example:
o Allergen cross-contact can result if equipment that is difficult to clean or is prone to
damage is used to produce foods that contain ingredients from different food allergen
sources.
o Allergen cross-contact can result from the unintentional addition of the wrong ingredient
to a food.
• Chemical hazards due to mis-formulation (e.g., sulfites, yellow #5) (Section 3.4.2.2.2)
o For example, mis-formulation can occur if you manufacture/process some products with
added sulfites and other products without sulfites, and if you unintentionally add sulfites
to a product that does not include sulfites in the product recipe.
• Process-contaminant hazards in certain plant-based foods (Section 3.4.2.3)
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o For example, some chemical hazards (such as acrylamide in certain plant-based foods
and 3-monochloropropane-1,2-diol esters (3-MCPDEs) and glycidyl esters (GEs)
(developed in some refined oils)) have the potential to form during food production,
particularly at high temperature.
21
See our website regarding 3-MCPDEs and GEs (Table
8 in section VI of the Introduction of this guidance) and the Codex Code of Practice CXC
79-2019 in Table 6 in section VI of the Introduction of this guidance.
22
See also Chapters 11 and 12 of this guidance; these chapters address food allergen controls
and preventive controls for chemical hazards, respectively, applicable to process-related
chemical hazards that require a preventive control.
As discussed in section 3.4.3 of Chapter 3 of this guidance, this guidance does not discuss
preventive controls for facility-related chemical hazards such as cleaning chemicals and the
leaching of heavy metals from containers or utensils, because such hazards are usually
addressed through CGMPs.
A1.7.3 The Most Relevant Process-related Physical Hazards
Section 3.5 in Chapter 3 of this guidance provides background information for the following
process-related and facility-related physical hazards that are most relevant to food safety:
• Metal (Section 3.5)
o For example, a process that uses a metal chopping blade could introduce metal
fragments if the blade breaks.
• Glass (when product is packed in glass) (Section 3.5)
o For example, a product packaged in glass containers could introduce glass fragments if
a container breaks.
• Hard plastic (Section 3.5)
o For example, hard plastic can be introduced into food when tools and equipment such as
scoops, paddles, buckets or other containers develop fatigue, crack, and break as they
wear, or when plastic sieves and screens deteriorate.
As discussed in section 3.5 in Chapter 3 of this guidance, in general there is overlap between
facility-related physical hazards and process-related physical hazards and, in evaluating the
potential for physical hazards in your food products, it does not matter whether you consider
physical hazards to be facility-related or process-related.
21
The Codex Alimentarius Commission, in which FDA participates, has developed recommendations for
industry on reducing 3-MCPDE and GE in refined oils and foods, particularly when a refined oil is used in
infant formula (Codex Code of Practice CXC 79-2019, Table 6 in section VI of the Introduction of this
guidance). FDA has focused its testing efforts on infant formula because infants are a vulnerable
population, infant formula contains relatively large amounts of oil (about 25-30%) to support infants’
nutritional needs, and, for some infants, infant formula is a sole food source. Because of the combined
efforts of industry and FDA, average 3-MCPDE and GE levels in infant formula in the U.S. have declined
over the last several years.
22
The draft Chapter 3 that we made available for public comment in 2016 did not discuss 3-MCPDE and
GE that can form during the production of refined oils. When we finalize that chapter, we intend to include
information about these process-related chemical hazards.
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See also Chapter 13 of this guidance, applicable to process-related and facility-related physical
hazards that require a preventive control.
A1.8 How to Use the Tables in Appendix 1
A1.8.1 Appendix 1 Reflects a Tiered Approach to the Requirements for
Hazard Analysis
As discussed in section A1.3, part 117 establishes a tiered approach to the requirements for
hazard analysis. This tiered approach considers three levels of hazards:
• The universe of hazards most relevant to food safety;
• Known or reasonably foreseeable hazards (“potential hazards”); and
• Hazards requiring a preventive control.
Under this tiered approach, you conduct your hazard analysis by first broadly considering the
universe of all hazards relevant to food safety and then, through the process of hazard
identification, narrowing that broad list of hazards to those hazards that are known or
reasonably foreseeable hazards (“potential hazards”) for your food products. You then
determine, through the process of hazard evaluation, the subset of those known or reasonably
foreseeable hazards (“potential hazards”) that are hazards requiring a preventive control. For
additional help in determining which known or reasonably foreseeable hazards (“potential
hazards”) require a preventive control, see Chapters 2 and 3.
The columns in the Tables in Appendix 1 list the most relevant hazards
23
, among the universe
of hazards for food safety, for 16 Food Groups. Hazards marked with an X for a Food
Subcategory are hazards that SMEs recommended be identified as known or reasonably
foreseeable hazards ("potential hazards") for subsequent hazard evaluation by each facility that
produces food products in those Food Subcategories.
A1.8.2 Hazards that SMEs Recommended Be Identified as Known or
Reasonably Foreseeable Hazards (“Potential Hazards”) Might Not Apply to All
Food Products in a Food Subcategory
The food products in a Food Subcategory, and the sources of food ingredients in the Food
Subcategories, are diverse. As a result, the recommendations of SMEs in the Tables in
Appendix 1 may not always apply to all food products in that Food Subcategory. For example, a
hazard marked with an X could:
• Be a known or reasonably foreseeable (“potential”) hazard only for some products in a Food
Subcategory. For example:
o Table 1O (Spices and Herbs) identifies Cyclospora as a known or reasonably
foreseeable (“potential”) biological hazard for some, but not all, herbs in two Food
Subcategories (2b and 3a).
23
For information on how we identified the most relevant biological and chemical hazards to address in
this Appendix, see sections A1.5.2, A1.6.1, and A1.6.2.
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o Table 1C (Food Additives, Color Additives, and GRAS Substances) identifies
Salmonella as a known or reasonably foreseeable (“potential”) biological hazard for
Flavors in Subcategory 5e (Ambient or Refrigerated Other Flavor Enhancer) because
the SMEs recommended that Salmonella be considered for one food product in this
subcategory (i.e., hydrolyzed vegetable protein), even though other food products in this
subcategory (such as monosodium glutamate) do not have a known or reasonably
foreseeable (“potential”) Salmonella hazard;
• Only be a known or reasonably foreseeable (“potential”) hazard when a food ingredient is
sourced from a specific geographic location (e.g., for chemical hazards such as toxic
elements and pesticides sourced from locations where there has been a history of such
contamination); or
• Only be a known or reasonably foreseeable (“potential”) hazard when a food ingredient is
used in a food that changes its characteristics (e.g., B. cereus in cooked (hydrated) rice but
not dried rice).
See the recommendation in Chapter 2 for you to record the reasons that led to the conclusions
of your hazard evaluation (i.e., the Yes/No conclusions listed in column 3 of Form 2-B).
Explaining your reasons for a “No” conclusion can be just as important as explaining your
reasons for a “Yes” conclusion. To be thorough and to have readily available answers to
questions about your hazard analysis, you may find it useful to take a conservative approach by
listing in Column 2 several known or reasonably foreseeable (“potential”) hazards even though
they clearly do not require a preventive control (especially when there has been significant
debate over whether something is actually a known or reasonably foreseeable (“potential”)
hazard for the facility), and explain the reasons for your “No” conclusion. This can be useful both
during your own review of your food safety plan and during review of your food safety plan by
others – e.g., if an inspector or auditor questions whether a particular hazard was considered.
A1.8.3 Each Facility Determines, Through Its Hazard Analysis, Those
Known or Reasonably Foreseeable Hazards (“Potential Hazards”) That
Require a Preventive Control
Each facility has the responsibility to determine, through its complete hazard analysis, whether
known or reasonably foreseeable hazards ("potential hazards") are hazards that require a
preventive control as appropriate to the facility and its food products. For example, a hazard
marked with an X in the Tables could be a hazard that does not require a preventive control if it
has a low probability of occurring in your food product in light of your facility and your food due
to:
• a process control that has exceptional lethality
24
for biological pathogens (e.g., when your
food product is caramel);
• the effectiveness of your CGMP practices in addressing the hazard (such as the
effectiveness of your CGMP hygiene procedures and policies in reducing the potential for
sick or infected employees to contaminate food); or
24
We intend to discuss processes that have “exceptional lethality” in our discussion of process validation
(Chapter 9). For example, processes that include boiling for several minutes might be considered
processes that provide “exceptional lethality” in that such boiling can provide a high level of reduction of
vegetative pathogens such as E. coli O157:H7, Salmonella spp. and L. monocytogenes.
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• likely preparation and handling steps before consumption (e.g., if your product is not an RTE
food (as defined in 21 CFR 117.3) and your product label provides the end user with
cooking instructions adequate to significantly minimize biological hazards).
A1.9 References
Section VII in the Introduction of this guidance includes all references cited in this guidance,
including any references cited in this Appendix. When a reference listed in section VII of the
Introduction of this guidance includes a website address, FDA has verified the website address,
as of the date that the Notice of Availability for the Introduction of this guidance publishes in the
Federal Register, but websites are subject to change over time.
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A1.10 Tables of Known or Reasonably Foreseeable (“Potential”) Food-Related Biological Hazards
Tables 1A through 1P list the most relevant food-related biological hazards for 16 Food Groups. The food-related biological hazards marked with
an X for a Food Subcategory are the food-related biological hazards that SMEs recommended be identified as known or reasonably foreseeable
("potential") biological hazards for subsequent hazard evaluation by each facility that produces food products in those Food Subcategories to
determine which of these biological hazards require a preventive control as appropriate to the facility and its food products. As discussed in section
A1.1 of this Appendix, this guidance, including Tables 1A through 1P, consistently uses a combined term (e.g., “known or reasonably foreseeable
(“potential”) biological hazard”) to describe the output of the Tables to consistently use both the term used in the regulatory text of part 117 and a
term that could be more familiar to some users of this guidance.
Tables 1A through 1P do not identify any hazards requiring a preventive control in any Food Subcategory. It is the responsibility of the owner,
operator, or agent in charge of each food facility to determine, through hazard analysis, whether a biological hazard identified in Tables 1A through
1P as a known or reasonably foreseeable (“potential”) biological hazard is a hazard requiring a preventive control in the facility’s food product.
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Table 1A: Known or reasonably foreseeable (“potential”) food-related biological hazards for Bakery Items
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Bread, Biscuits,
Rolls, Brownies,
Cookies, Pizza,
Pie Crust
1
- Unbaked Bakery
Items
- Ready-To-Bake
(RTB) Dough
- RTB Crust
- With or Without
Inclusions
1
Refrigerated or
Frozen
X X X
Includes bagels,
croissants, puff pastry,
phyllo
Bread,
Whole/Pre-sliced
2a
- Fully-Baked
- With or without
Pre-Bake Added
Filling or
Inclusions
1
- Without Post-
Bake Added
Frosting/Topping
Ambient,
Refrigerated or
Frozen
X X X
Includes biscuits,
bagels, rolls, croissants
Bread,
Whole/Pre-sliced
2b
- Fully-Baked
- With or without
Pre-Bake Added
Filling or
Inclusions
1
- With Post-Bake
Added Filling,
Frosting, and/or
Topping
Ambient,
Refrigerated or
Frozen
X X X X
Includes bread with
drizzles/ frosting
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Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Brownies /
Cookies
3a
- Fully-Baked
- With or without
Pre-Bake Added
Filling or
Inclusions
1
- Without Post-
Bake Added
Frosting/ Topping
Ambient X X X
Includes biscotti; fruit
filled bars/wafers
Brownies /
Cookies
3b
- Fully-Baked
- With or without
Pre-Bake Added
Filling or
Inclusions
1
- With Post-Bake
Added Filling,
Frosting, and/or
Topping
Ambient X X X X
Includes fruit-, cream-
or chocolate-filled bars/
wafers
Cakes/Muffins/
Quick Breads
4a
- Fully-Baked
- With or without
Pre-Bake Added
Filling or
Inclusions
1
- Without Post-
Bake Added
Frosting/ Topping
Ambient,
Refrigerated, or
Frozen
X X X
- Includes all flavors
and densities
- Includes all fillings
added before baking
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Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Cakes/Muffins/
Quick Breads
4b
- Fully-Baked
- With or without
Pre-Bake Added
Filling or
Inclusions
1
- With Post-Bake
Added Filling,
Frosting, and/or
Topping
Ambient,
Refrigerated or
Frozen
X X X X
Includes tortes and
products with post-
bake added cream,
nuts, confectionery and
dried fruits and layer
cakes with fillings or
frosting
Croutons/Bread
Crumbs
5
Other Bakery
Products
Ambient X X X
Includes unseasoned
and seasoned products
Custard Pies 6
- Unbaked Bakery
Items
- Ready-To-Bake
(RTB) Crust and
Filling
Frozen X X X
Includes pies with egg-
and milk-derived
ingredients
Custard/Cream
2
/
Crème Pie/
Cheesecake
7a
- Fully-Baked/
Cooked
- With or Without
Pre-Cook Added
Fillings
- Without Post-
Bake Added
Frosting/Topping
Ambient,
Refrigerated or
Frozen
X
3
X
3
X X X
Includes cheesecake
and pies with egg- and
milk-derived
ingredients
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Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Custard/Cream
2
/
Crème Pie/
Cheesecake
7b
- Fully-Baked/
Cooked
- With Post-Bake
Added Frosting/
Topping
Ambient,
Refrigerated or
Frozen
X
3
X
3
X X X
X
Includes cheesecake
and pies with whipped
cream topping
Dry Mixes 8
Other Bakery
Products
Ambient X X X
Includes mixes for
breads, quick breads,
pancakes, cookies,
cakes, brownies,
biscuits, breading, pie
crust
Fruit
Pies/Cobblers
9a
Unbaked Bakery
Items
Frozen X X X
Includes all fruits and
fruit mixtures
Fruit
Pies/Cobblers
9b
- Fully-Baked
- With or Without
Pre-or Post- Bake
Added Fillings,
Frosting, and/or
Topping
Ambient,
Refrigerated, or
Frozen
X X X
Includes all fruits and
fruit mixtures
Ice Cream
Cones
10
Other Bakery
Products
Ambient X X X
Includes plain and
sugar cones
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Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Liquid Batter 11
Unbaked Bakery
Items
Refrigerated X
3
X
3
X X X X
Includes batters for
pancakes, brownies,
waffles, doughnut
Other Pastry
Products
12a
- Fully-Baked
- With or Without
Pre-Bake Added
Filling
- Without Post-
Bake Added
Frosting/Topping
Refrigerated or
Frozen
X X X
Includes several
breakfast items, such
as French toast,
pancakes, waffles
Other Pastry
Products
12b
- Fully-Baked
- With Post-Bake
Added Filling,
Frosting and/or
Topping
Ambient,
Refrigerated or
Frozen
X X X X
Includes Danishes,
éclairs, cream puffs,
cannoli, doughnuts,
toaster pastries,
turnovers
Tortillas, Soft
Shell/Hard Shell
13
Other Bakery
Products
Ambient or
Refrigerated
X X X
Includes tortillas made
with corn, wheat, rice,
quinoa
1
If your food product includes an inclusion, your hazard analysis should also consider known or reasonably foreseeable (“potential”) biological hazards
associated with the inclusion (e.g., hazards for nuts, chocolate chips, fruit). The other tables in section A1.10 are resources that could be applicable to the
inclusion.
2
In a cream/crème pie, the crust is baked and then a cooked filling is added to the baked crust. In a custard pie, the filling is poured into the crust and then the
filling and crust are baked at the same time.
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3
The SMEs noted that whether these pathogenic sporeformers are known or reasonably foreseeable (“potential”) biological hazards that could require
time/temperature controls depends on the product (e.g., pH, water activity) and the process used to make the product.
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Table 1B: Known or reasonably foreseeable (“potential”) food-related biological hazards for Beverage Items
Category # Subcategory
Storage
Conditions
Bacillus
cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Non-dairy
Cocoa/
Chocolate
1a Ready-to-Drink Refrigerated X
1
X
1
X
Includes plant-
based
chocolate/
cocoa-flavored
drinks
Non-dairy
Cocoa/
Chocolate
1b
Powdered
Beverages
Ambient X
Includes plant-
based
chocolate/
cocoa-flavored
products
Coffee 2a
- Roasted Beans
- Whole or
Ground
Ambient X
Includes
flavored, non-
flavored, and
single serve
Coffee 2b
- Ready-to-Drink
- Unflavored and
Flavored
Refrigerated
X
1
X
1
X
Includes
brewed coffee
and espresso-
style coffee
Coffee 2c
- Powdered
- Freeze Dried
Ambient X
Includes instant
coffees,
cappuccino mix
Coffee 2d
Concentrated
Liquid Base
Mixes
Refrigerated
X
1
X
1
X
Includes plain
and flavored
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Category # Subcategory
Storage
Conditions
Bacillus
cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Dairy-Based 3 Ready-to-Drink Refrigerated X
1
X
1
X X X
Includes
flavored and
unflavored fluid
milk from
multiple
species, yogurt
drinks, kefir
Non-Dairy
2
4a
- Ready-to-Drink
Milk Substitutes
- Plain and
Flavored
Refrigerated X
1
X
1
X X X
Includes plant-
based
beverages and
non-dairy liquid
creamer
Non-Dairy 4b
Powdered Coffee
Creamer
Ambient X
Includes plain
and flavored
Juice-Based
2
5
Ready-to-Drink
(not 100% juice)
Ambient
3
or
Refrigerated
X
1
X
1
X X
All fruit drinks
with some juice
content
Tea and Tea
Substitutes
6a
Loose Leaf and
Bagged
Ambient X X
Includes
flavored and
non-flavored
teas and herbal
teas
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Category # Subcategory
Storage
Conditions
Bacillus
cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Tea and Tea
Substitutes
6b
- Instant
- Powdered
Ambient X X
Includes
flavored and
non-flavored
teas and herbal
teas
Tea and Tea
Substitutes
6c Ready-to-Drink
Ambient
3
or
Refrigerated
X X
Includes
flavored and
non-flavored
teas and herbal
teas
Tea and Tea
Substitutes
6d
Concentrated
Liquid Base
Mixes
Ambient
3
or
Refrigerated
X X
Includes plain
and flavored
and herbal teas
Carbonated
Beverages
7
- Ready-to-Drink
- Carbonated
Ambient
Bottled drinking
water is subject
to the
processing and
bottling
requirements of
21 CFR part
129 and the
microbiological
criteria in 21
CFR 165.110(b)
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Category # Subcategory
Storage
Conditions
Bacillus
cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Uncarbonated
Beverages
8
- Ready-to-Drink
- Uncarbonated
Waters
Ambient
Bottled drinking
water is subject
to the
processing and
bottling
requirements of
21 CFR part
129 and the
microbiological
criteria in 21
CFR 165.110(b)
Sports and
Energy
Beverages
9 Ready-to-Drink
Ambient
3
or
Refrigerated
X
3
All varieties
Beverage
Concentrates/
Base Mixes
2
10a Liquid
Ambient
3
or
Refrigerated
Includes bases
for carbonated
beverages and
syrups for
flavored drinks
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Category # Subcategory
Storage
Conditions
Bacillus
cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Beverage
Concentrates/
Base Mixes
10b Dry Powdered Ambient
Includes
powdered
flavors
Adult
Beverage
Mixers
2
11
Mixes intended
for alcoholic
beverages (liquid
and powders)
Ambient
3
or
Refrigerated
X
1
X
1
X All varieties
Ground
Coffee
Substitutes
12 Dry Powdered Ambient X
4
X
4
Includes chicory
root powder,
roasted grains
1
The SMEs noted that whether these pathogenic sporeformers are known or reasonably foreseeable (“potential”) biological hazards that could require
time/temperature controls depends on the product (e.g., pH, water activity) and the process used to make the product.
2
Depending on the ingredients there could be other hazards. Refer to other tables for the ingredients.
3
There may not be any known or reasonably foreseeable (“potential”) biological hazard applicable to shelf-stable products. Shelf-stable products that are LACF
products are not subject to the requirements for biological hazards in 21 CFR Part 117. Shelf-stable non-LACF products generally are produced using an
exceptionally lethal process. (See the discussion of exceptionally lethal processes in section A1.6.1.3.)
4
The SMEs identified this as a known or reasonably foreseeable (“potential”) biological hazard applicable only when the beverage includes an herb.
5
See Table 1J for the known or reasonably foreseeable (“potential”) biological hazards associated with the applicable roasted grain.
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Table 1C: Known or reasonably foreseeable (“potential”) food-related biological hazards for Miscellaneous Food Additives,
Color Additives, and GRAS Substances
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Emulsifiers 1 Emulsifiers
Ambient or
Refrigerated
X
3
Includes substances
such as lecithin (from
soy, safflower, or
corn oil or from egg)
mono- and
diglycerides,
polysorbates,
sorbitan
monostearate
Stabilizers and
Thickeners
2a Firming Agents Ambient
Includes substances
such as calcium
chloride, calcium
lactate
Stabilizers and
Thickeners
2b Humectants Ambient
Includes substances
such as glycerin,
sorbitol
Stabilizers and
Thickeners
2c
Leavening
Agents
Ambient
X
3
Includes substances
such as baking soda,
monocalcium
phosphate, calcium
carbonate, dried
yeast
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Category # Subcategory Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Stabilizers and
Thickeners
2d
Stabilizers,
Thickeners,
Binders,
Texturizers
A
mbient
X
Includes substances
such as gelatin,
pectin, carrageenan,
modified starches,
acacia gum, guar
gum, xanthan gum
Stabilizers and
Thickeners
2e
Dough
Strengtheners
and
Conditioner
Ambient
Includes substances
such as ammonium
sulfate,
azodicarbonamide,
and l-cysteine
Stabilizers and
Thickeners
2f
Anti-caking
Agents
Ambient
Includes substances
such as calcium
silicate, iron
ammonium citrate,
silicon dioxide
Enzymes 3
Bakery,
Proteolytic,
Starch/Sugar
Liquefication,
Cheese-
making
Refrigerated X
Includes substances
such as amylases,
chymosin, lactase,
lipase, papain,
proteases, xylanase
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 44
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Colors 4a Certified Colors Ambient
Includes FD&C
colors listed in 21
CFR part 74, subpart
A
Colors 4b
Colors Exempt
from
Certification
Ambient or
Refrigerated
Includes colors listed
in 21 CFR part 73,
subpart A
Flavors 5a
Liquid: Oil-
Based
1, 2
Ambient or
Refrigerated
Includes a variety of
oil-based flavor
extracts from plants
Flavors 5b
Liquid:
Aqueous
Ambient
Includes a variety of
non-oil-based flavor
extracts from plants
Flavors 5c
Powdered:
Natural Flavor
Ambient or
Refrigerated
Includes a variety of
powdered flavor
extracts from plants
Flavors 5d
Artificial:
Synthetic
Flavor
Ambient or
Refrigerated
Includes a variety of
synthetic flavors
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 45
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Flavors 5e
Other: Flavor
Enhancer
Ambient or
Refrigerated
X
Includes substances
such as monosodium
glutamate, autolyzed
yeast extract,
hydrolyzed vegetable
proteins, disodium
guanylate, inosinate
Flavors 5f Flavor Paste
Ambient or
Refrigerated
X X X
Includes a variety of
plant-based flavor
pastes
Other Chemical
Ingredients
6a
Processing
Chemicals
Ambient
Includes substances
such as potassium
hydroxide, potassium
bicarbonate, sodium
chloride, hydrochloric
acid, sodium
hydroxide, calcium
carbonate, calcium
lactate, mineral oil
Other Chemical
Ingredients
6b Organic Acids Ambient
Includes substances
such as acetic acid,
citric acid, lactic acid,
fumaric acid
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Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Other Chemical
Ingredients
6c Antioxidants
Ambient or
Refrigerated
Includes substances
such as butylated
hydroxy toluene
(BHT), d-alpha-
tocopherol acetate
(TOCO)
Other Chemical
Ingredients
6d
Antimicrobials
and
Preservatives
Ambient or
Refrigerated
Includes substances
such as nisin,
potassium sorbate
Other Chemical
Ingredients
6e
Processing Aid
Gases
Ambient
Includes gases such
as nitrogen, carbon
dioxide
Other Chemical
Ingredients
6f Soluble Fiber Ambient
Includes substances
such as inulin,
fructan
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 47
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Nutrients 7
Vitamins,
Minerals, and
Vitamin/Mineral
Premixes
Ambient or
Refrigerated
Includes substances
such as thiamine
hydrochloride,
riboflavin, niacin,
niacinamide, folate or
folic acid, beta
carotene, potassium
iodide, iron or ferrous
sulfate, alpha
tocopherols, ascorbic
acid, Vitamin D,
magnesium sulfate
1
Although the SMEs identified known or reasonably foreseeable (“potential”) biological hazards in the source plant of some of these oils (e.g.,
sesame, almond), such hazards have not been found in the oils.
2
See also Category 3b (Essential oils) in Table 1O (Spices and Herbs).
3
Salmonella has been isolated from soy lecithin (Food Navigator.co, 2006; and The Brussels Times, 2022a and b) and dried yeast (Wilson et al.,
1975).
Contains Non-binding Recommendations
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Table 1D: Known or reasonably foreseeable (“potential”) food-related biological hazards for Chocolate and Candy
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Chocolate
Industrial
Products
1a
Raw Cocoa
Beans
Ambient X Cocoa Beans
Chocolate
Industrial
Products
1b
Roasted Cocoa
Beans and Nibs
Ambient X Beans and Nibs
Chocolate
Industrial
Products
1c
Chocolate/Cocoa
Products for
Baking
Ambient X
Includes chocolate products
with varying sweetness and
includes bulk solid (blocks),
bulk molded (chips),
bulk powder, and bulk liquid
Confectionary
Industrial
Products
2a
Other Products
for Baking
Ambient X
Includes bulk molded (e.g.,
peanut butter chips, caramel
chip) and bulk liquid
Confectionary
Industrial
Products
2b
Chocolate
Coating for
Enrobing
Ambient X
Includes bulk solid and bulk
liquid products
Chocolate and
Confectionery
Products
3a
Chocolate
Confections
Ambient X
Includes bars, chips, morsels,
fudge, bonbons
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 49
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Chocolate and
Confectionery
Products
3b
Chocolate
Confections -
With Inclusions
1
Ambient
Includes chocolate covered
nuts/ fruit/ caramel/ mints,
biscuits, nougats; chocolate
candy bar with nuts or fruit;
chocolate with crisped rice;
fudge with nuts
Confectionery
Products
3c
Sugar
Confections
2
Ambient
Includes caramels, gummy gel
candies, fruit chews, licorice,
marshmallows, soft jellied
candy, gel cups candy, maple
creams, fondant, pastilles, rock
candy, hard candy
Confectionery
Products
3d
Sugar
Confections with
inclusions
1
Ambient
Includes nut brittles (peanut
brittle, almond brittle), nut
clusters, candy with fruit pieces
Confectionery
Products
3e
Sugar
Confections
Specialties
Ambient X
Includes candy coated
popcorn, cereal confection,
marzipan, coconut roll, peanut
butter fudge, cotton candy
2
,
pastes
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 50
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Toppings/
Frosting
4
Toppings and
Frosting (Non-
Fruit/Nut)
Ambient X
3
All flavors and varieties
1
With the exception of inclusions (e.g., nuts, chocolate chips, fruit) added after the cooking process for the chocolate confection is complete, the SMEs did not
identify any known or reasonably foreseeable (“potential”) biological hazards for
products found in this Food Subcategory because the products are processed
by an “exceptionally lethal process.” (See the discussion of exceptionally lethal processes in section A1.6.1.3.) If your food product includes an inclusion added
after the cooking process for the chocolate confection, your hazard analysis should also consider known or reasonably foreseeable (“potential”) biological
hazards associated with the inclusion (e.g., hazards for nuts, chocolate chips, fruit). The other tables in section A1.10 are resources that could be applicable to
the inclusion.
2
The SMEs did not identify any known or reasonably foreseeable (“potential”) biological hazards for
products found in this Food Subcategory or identified in the
comment box because the products are processed by an “exceptionally lethal process.” (See the discussion of exceptionally lethal processes in section A1.6.1.3.)
3
The SMEs identified a known or reasonably foreseeable (“potential”) Salmonella hazard only if the product contains ingredients for which Salmonella is a
known or reasonably foreseeable (“potential”) hazard. See the applicable Table for any known or reasonably foreseeable (“potential”) hazards associated with
the ingredients of your food product.
Contains Non-binding Recommendations
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 51
Table 1E: Known or reasonably foreseeable (“potential”) food-related biological hazards for Dairy
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Raw
1
Milk 1
Liquid Milk for
Processing
Refrigerated X
2
X
2
X X X X X X Raw fluid milk
Milk and Butter 2a
Liquid Milk
products
Ambient
3
or
Refrigerated
X
2
X
2
X X X
Includes flavored and
unflavored fluid milk
from multiple species
(cow, goat, sheep),
ultra-pasteurized
milks, milk-based
creamer
Milk and Butter 2b Cream products Refrigerated X
2
X
2
X X X
Includes heavy, light,
whipping creams and
half-and-half
Milk and Butter 2c Butter products Refrigerated X X X X
Includes butter
spreads and blends
Milk and Butter 2d
Cultured milk
products
Refrigerated X X X
Includes buttermilk,
sour cream, yogurt,
yogurt drinks, kefir
Milk and Butter 2e
Dry milk
products
4
Ambient X
5
X X X
Includes dried
products extracted
from milk, such as
whey powder and
dried milk products
used in dried dips
Contains Non-binding Recommendations
Draft-Not for Implementation
Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 52
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Milk-Based
Products
3a
Ice cream,
regular and low
fat (with and
without
inclusions)
6
Frozen
X X X All flavors
Milk-Based
Products
3b Sherbets Frozen
X X X All flavors
Milk-Based
Products
3c
Frozen Novelty
Items
Frozen
X X X
Includes ice cream
cakes/bars/
sandwiches, frozen
yogurt
Cheese and
Cheese Products –
Whole
4a
Extra Hard
Cheese (low pH,
low water activity)
Ambient or
Refrigerated
X X X X
Includes Parmesan,
Asiago, Romano,
Sbrinz
Cheese and
Cheese Products –
Whole
4b Hard Cheese Refrigerated
X X X X
Includes Cheddar,
Colby, Swiss, Gruyere
Cheese and
Cheese Products –
Whole
4c Semi-soft Cheese Refrigerated
X X X X
Includes Monterey,
Provolone, Oaxaca,
Monterey Jack, Edam,
Havarti, Paneer,
Raclette
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 53
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Cheese and
Cheese Products –
Whole
4d
Soft, Ripened
Cheese
Refrigerated
X X X X
Includes Brie,
Camembert, Taleggio
Cheese and
Cheese Products –
Whole
4e
Soft, Unripen
Cheese/ Fresh
Cheese
Refrigerated
X X X X
Includes Cottage
Cheese, Cream
Cheese, Ricotta,
Queso Fresco,
Cheese Curd,
Mozzarella
Cheese and
Cheese Products -
Sliced, Shredded,
or Grated
5a
Hard and Extra
Hard Cheese
Ambient or
Refrigerated
X X X X
Includes Parmesan,
Asiago, Romano,
Cheddar
Cheese and
Cheese Products -
Sliced, Shredded,
or Grated
5b
Semi-soft Cheese Refrigerated
X X X X
Includes Monterey,
Provolone, Oaxaca,
Monterey Jack
Cheese and
Cheese Products -
Sliced, Shredded,
or Grated
5c
Pasteurized
Process Cheese
Ambient
7
or
Refrigerated
Includes Process
American Cheese
Contains Non-binding Recommendations
Draft-Not for Implementation
Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 54
1
Milk and cream, and butter made from them, in this Table are considered “pasteurized” under 21 CFR 1240.61 and the Pasteurized Milk Ordinance. Raw milk is
only used in certain cheeses that are aged for at least 60 days. Brucella spp. and Campylobacter spp. are not identified as known or reasonably foreseeable
(“potential”) hazards for Food Categories other than Raw Milk because processes targeting the principal pathogens associated with dairy products will also
address these pathogens and they generally are not reintroduced into milk after it has been pasteurized.
2
The SMEs noted that whether these pathogenic sporeformers are known or reasonably foreseeable (“potential”) biological hazards that could require
time/temperature controls depends on the product (e.g., pH, water activity) and the process used to make the product.
3
Excludes LACF (shelf-stable) products (including evaporated and sweetened and condensed milk products), which are not subject to the requirements for
biological hazards in 21 CFR Part 117.
4
We recommend that you also consider Cronobacter spp. (including C. sakazakii) as a known or reasonably foreseeable (“potential”) biological hazard when milk
powders are destined for use in dry blended powdered infant formula products. A facility that manufactures/processes powdered infant formula is subject to
the microbiological criteria in 21 CFR 106.55(e) for when a powdered infant formula that contains Cronobacter spp. will be deemed adulterated under sections
402(a)(1), 402(a)(4), and 412(a)(3) of the FD&C Act.
5
The SMEs identified this as a known or reasonably foreseeable (“potential”) biological hazard applicable only when the food is used as an ingredient in another
product where the dried milk becomes hydrated.
6
If your food product includes an inclusion, your hazard analysis should also consider known or reasonably foreseeable (“potential”) biological hazards
associated with the inclusion (e.g., hazards for nuts, chocolate chips, fruit). The other tables in section A1.10 are resources that could be applicable to the
inclusion.
7
Excludes LACF (shelf-stable) pasteurized process cheese products (e.g., jars of cheese spreads), which are not subject to the requirements for biological hazards
in 21 CFR Part 117.
Contains Non-binding Recommendations
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 55
Table 1F: Known or reasonably foreseeable (“potential”) food-related biological hazards for Dressings, Condiments, and Dips
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Condiments 1a Mayonnaise
Ambient or
Refrigerated
X X X
Includes regular and
“lite” products and
flavored products
Condiments 1b Mustard
Ambient or
Refrigerated
X X X
Includes all varieties
Condiments
1c
Ketchup
Ambient
X
X
X
Includes all varieties
Condiments
1d
Vinegar
Ambient
Includes all varieties
Condiments 1e
Other
Condiments
Ambient
Includes soy sauce,
Worcestershire sauce,
prepared horseradish,
steak sauce, Tabasco
sauce
Salad
Dressings
2a
Dressings,
salad
(prepared)
Ambient or
Refrigerated
X X X
Includes all varieties
Salad
Dressings
2b Dry mixes Ambient X X
Includes all varieties
Contains Non-binding Recommendations
Draft-Not for Implementation
Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 56
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Dips 3a
Dips and
spreads
Ambient
1
or
Refrigerated
X X X X X X
Includes dips and
spreads such as
guacamole, salsa,
dairy-based dips,
bean dips, sesame-
based dips (e.g.,
hummus, tahini,
vegetable dips, taco
Dip, 7-layer dip
Dips 3b
Dips and
spreads, dry
Ambient X
2
X
2
X X X
Dry dips, dry dairy-
based dips (e.g.,
vegetable dip
seasoning, toasted
onion dip mix)
1
Excludes LACF (shelf-stable) products which are not subject to the requirements for biological hazards in 21 CFR Part 117.
2
The SMEs identified known or reasonably foreseeable (“potential) biological hazards for sporeformers that would apply only when these products are
rehydrated and/or used as an ingredient in a product where pH would permit growth.
Contains Non-binding Recommendations
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 57
Table 1G: Known or reasonably foreseeable (“potential”) food-related biological hazards for Egg and Egg Products
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Shell Eggs 1 Shell Eggs Refrigerated X
Includes raw and
pasteurized in-
shell
Further
Processed Egg
Products
2a
Eggs Hard
Cooked
Refrigerated X X
Includes eggs in
shell or shelled
Further
Processed Egg
Products
2b
Cooked Egg
Products
Refrigerated or
Frozen
X X
Includes cooked
products such as
omelets, egg
patties, scrambled
eggs
Further
Processed Egg
Products
3
Egg-based
products and egg
substitutes (not
fully cooked)
1
Refrigerated or
Frozen
X
For use as an
ingredient
1 As discussed in section A1.6.1.4, the production of certain processed egg products (e.g., pasteurized liquid whole egg) is subject to regulation by USDA’s FSIS
under the Egg Products Inspection Act. However, these processed egg products could be used as ingredients in foods subject to FDA’s jurisdiction.
Contains Non-binding Recommendations
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 58
Table 1H: Known or reasonably foreseeable (“potential”) food-related biological hazards for Fruits and Vegetables
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium
botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Fruits 1 Whole RAC
Ambient or
Refrigerated
X X X X
1
X
2
All whole RAC
fruits
Processed
Fruits
2a Fresh-cut Refrigerated X X X X
1
X
2
All fresh-cut fruit,
including
individual fruit
and mixed fruit
Processed
Fruits
2b Whole or Cut Frozen X X X X
1
X
2
All frozen fruit
Processed
Fruits
2c
Heat Treated
Fruit Products
Ambient
3,4
or
Refrigerated
X X X
Includes
individual and
mixed fruit (e.g.,
fruit and mixed
fruit in juice or
syrup)
Processed
Fruits
2d
Dried/
Dehydrated Fruit
Products
Ambient X X X
All dried/
dehydrated fruits
Processed
Fruits
2e
Jams, Jellies,
Chutneys
4
Ambient All varieties
Contains Non-binding Recommendations
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 59
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium
botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Processed
Fruits
2f Coated Fruits
5
Refrigerated X
All coated fruits
(e.g., caramel
apples with
inserted stick,
chocolate
covered
strawberries)
Vegetables 3 Whole RAC
Ambient or
Refrigerated
X
6
X X X X X
7
All whole RAC
vegetables
Processed
Vegetables
4a Fresh-cut Refrigerated X
6
X X X X
All fresh-cut
vegetables
Processed
Vegetables
4b Whole or Cut Frozen X X X
All frozen
vegetables
Processed
Vegetables
4c
Whole or cut,
Heat treated
Refrigerated X X X X X
All heat-treated,
refrigerated
vegetables, such
as mashed
potatoes and
roasted
vegetables
Processed
Vegetables
4d
Acidified
Products
Ambient X X X X X
All ambient
acidified
vegetables and
vegetable
mixtures (such
as in salsas)
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 60
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium
botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Processed
Vegetables
4e
Dried/
Dehydrated
Products
Ambient X
8
X
8
X X X
All dried/
dehydrated
vegetables
Processed
Vegetables
4f
Fermented
Products
Ambient X X X X X
Includes
sauerkraut,
pickles, kimchi
Processed
Fruits or
Vegetables
5
Acid Pureed
Products
Ambient X X X
Includes
applesauce,
apple butter,
tomato paste
1
The SME identification of the parasite Cyclospora as a known or reasonably foreseeable (“potential”) biological hazard in this subcategory primarily applies to
berries and berry-containing products that have not been heat treated sufficiently to inactivate Cyclospora, but could also apply to other produce from areas
where Cyclospora has been determined to be present, e.g., in the water supply.
2
The SME identification of viruses (such as norovirus and hepatitis A) as known or reasonably foreseeable (“potential”) biological hazards is limited to berries,
pomegranates (the arils), and any fresh, refrigerated, or frozen products containing berries or pomegranate.
3
Excludes LACF (shelf-stable) products such as heat-treated canned mangoes, which are not subject to the requirements for biological hazards in 21 CFR Part
117.
4
The SMEs did not identify any known or reasonably foreseeable (“potential”) biological hazards for
shelf-stable products found in this Food Subcategory
because the products are processed by an “exceptionally lethal process.” (See the discussion of exceptionally lethal processes in section A1.6.1.3.)
5
Your hazard analysis should also consider known or reasonably foreseeable (“potential”) biological hazards associated with the coating (e.g., hazards for
chocolate) and the specific fruits being coated. The other tables in section A1.10 are resources that could be applicable to the coating.
6
See the discussion, in Chapter 3 of this guidance, of the potential for reduced oxygen packaging (ROP) to create a process-related biological hazard. When we
finalize Chapter 3, we intend to emphasize that this risk may not apply to all fresh and fresh-cut produce RACs (e.g., we are not aware of reports of botulism
associated with commercially available fresh-cut leafy greens packaged in ROP). We also intend to emphasize the importance of evaluating whether ROP
presents an increased risk from sporeforming pathogens in your specific food product when deciding whether to use ROP.
Contains Non-binding Recommendations
Draft-Not for Implementation
Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 61
7
The SME identification of parasites (such as Cyclospora) as a known or reasonably foreseeable (“potential”) biological hazard in this subcategory primarily
applies to fresh herbs (such as basil and cilantro) and uncooked foods containing these herbs, but could also apply to other produce from areas where
Cyclospora has been determined to be present, e.g., in the water supply.
8
The SMEs identified known or reasonably foreseeable (“potential”) biological hazards only when the food is used as an ingredient in another product where the
dehydrated vegetable becomes hydrated.
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 62
Table 1I: Known or reasonably foreseeable (“potential”) food-related biological hazards for Game Meat Products
1
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Raw Game
Meat
1a
Intact (Not
Ground) Game
Meat
Refrigerated or
Frozen
X X X X X
2
Intact meat from
all game species
(e.g., bison,
deer, elk, rabbit,
and birds (such
as pheasant,
grouse, quail))
Raw Game
Meat
1b
Ground Game
Meat
Refrigerated or
Frozen
X X X X X X
2
Ground meat
from all game
species
Game Meat
Products
2a
Processed
Game Meat
Products
Ambient X X X X X
Processed
products such
as jerky
Game Meat
Products
2b
Processed
Game Meat
Products
Refrigerated X X X X X
Processed
products such
as sausages,
patties,
frankfurters,
salami
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 63
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Game Meat
Products
2c
Processed
Game Meat
Products
Frozen
X
X X X X
Processed
products such
as sausages,
patties,
frankfurters,
salami
1
The SMEs identified known or reasonably foreseeable (“potential”) biological hazards in the broad category “Game Meat Products” but did not
differentiate between species (e.g., bison, deer, rabbit).
2
Toxoplasma gondii is associated with deer and elk.
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 64
Table 1J: Known or reasonably foreseeable (“potential”) food-related biological hazards for Grains, Pulses, Flours, and
Starches
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Grains 1 Whole, grains Ambient X
1
X
1
X X X All whole grains
Grains, Milled
Products
2a
Flours (other
than rice flour,
corn flour, and
root flour)
Ambient X
1
X
1
X X X
All flours from grains
(except as noted in the
subcategory); includes
gluten
Grains, Milled
Products
2b
Rice and rice
products
Ambient X
1
X
1
X
Includes all varieties of
rice and rice-based
noodles
Grains, Milled
Products
2c Malt Ambient X
Includes all malted grain
products
Grains, Milled
Products
2d Corn Ambient X
1
X Cornmeal, corn flour
Grain-based
Cereal
Products
3a
Cereal
Product:
Ready-to-Eat
Ambient
X
Includes cereal products
with and without
inclusions
2
Grain-based
Cereal
Products
3b
Breakfast
food, dried
Ambient X
1
X
Includes products such as
oatmeal, farina, oat bran,
cream of wheat, grits
Grain-based
Pasta
Products
4a Unfilled Pasta
Refrigerated
or Frozen
X
1
X
1
X X X All varieties
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 65
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Grain-based
Pasta
Products
4b
Filled Par-
boiled Pasta
Refrigerated
or Frozen
X
1
X
1
X X X All varieties
Grain-based
Pasta
Products
4c Dried Pasta Ambient X
1
X
1
X
1
X All varieties
Other Milled
Products
5a Root flours Ambient X
1
X
All root flours (e.g., from
potatoes, cassava)
Other Milled
Products
5b
Starch
products
Ambient X
1
X
Cornstarch, Potato
Starch, Wheat Starch
Pulses
3
6a
Whole, dried
Ambient
X
1
X
1
X
1
X
X
Includes all pulses
Pulses
3
6b
Cooked
pulses
Ambient,
4
Refrigerated
or Frozen
X X X X X X Includes bean paste
1
The SMEs identified this as a known or reasonably foreseeable (“potential”) biological hazard applicable only when the food becomes hydrated to an a
w
that
allows growth or is used as an ingredient in another product where the grains/pulse/flour/starch become hydrated to an a
w
that allows growth.
2
If a cereal product contains one or more inclusions (such as nuts or chocolate), your hazard analysis should also consider known or reasonably foreseeable
(“potential”) biological hazards associated with the inclusion (e.g., hazards for nuts, chocolate chips, fruit). The other tables in section A1.10 are resources that
could be applicable to the inclusion.
3
Pulses are the dried, edible, pod-grown seed from produce (such as peas, beans, or lentils) within the legume family. Pulses include commodities such as
bambara beans; chickpeas; cowpeas; dry beans (such as adzuki, black, flageolet, great northern, kidney, lima, mung, navy, pink, pinto, and tepary beans); dry
broad beans; dry peas; lentils; and pigeon peas.
4
Excludes LACF (shelf-stable) products such as canned pulses or bean pastes, which are not subject to the requirements for biological hazards in 21 CFR Part 117.
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 66
Table 1K: Known or reasonably foreseeable (“potential”) food-related biological hazards for Nuts and Seeds
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Nuts
1a
Peanuts, Raw
Ambient
X
X
X
Peanuts
Nuts 1b
Peanuts Roasted
or Boiled
Ambient X X X Peanuts
Nuts
1c
Tree Nuts, Raw
Ambient
X
X
X
Includes all tree nuts
Nuts 1d
Tree Nuts,
Roasted
Ambient X X X Includes all tree nuts
Nuts 1e Nut Butters Ambient X X X
Includes product from
peanuts and tree nuts
Edible Seeds 2a Raw Ambient X X X
Includes edible seeds
from flax, melon,
pumpkin, sesame,
sunflower
Edible Seeds 2b Roasted Ambient X X X
Includes edible seeds
from flax, melon,
pumpkin,
sesame, sunflower
Other Nut and
Seed Products
3a
Nut and Seed
Pastes
Ambient X
X X
Includes pastes from
peanuts, tree nuts, and
seeds, seeds
Other Nut and
Seed Products
3b
Nut and Seed
Flours
Ambient X X X
Includes flour from
peanuts, tree nuts, and
seeds
Contains Non-binding Recommendations
Draft-Not for Implementation
Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 67
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Other Nut and
Seed Products
3c
Coconut Products
Ambient,
Refrigerated,
or Frozen
X X X
Includes shredded,
flaked, and toasted
products
Contains Non-binding Recommendations
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 68
Table 1L: Known or reasonably foreseeable (“potential”) food-related biological hazards for Oils and Oil Products
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Oil Products 1a Cooking Oils Ambient
Includes single oils and oil
blends
Oil Products 1b
Margarines and
other spreads
Ambient or
Refrigerated
Includes all varieties
Oil Products 1c Shortening Ambient
Includes varieties
considered as imitation/
substitute and includes
partially and fully
hydrogenated vegetable
oils
Oil Products 1d Infused Oils Ambient X
1
Includes oils infused with
acidified or non-acidified
ingredients
Oil Products 1e
Cocoa Butter
and Cocoa
Butter
Substitutes
Ambient
Includes cocoa butter and
cocoa butter substitutes
(e.g., from coconut oil,
palm kernel oil, or both
oils (21 CFR 172.861) or
primarily from palm oil or
primarily from high-oleic
safflower or sunflower oil
(21 CFR 184.1259)
1
The SMEs only identified C. botulinum as a known or reasonably foreseeable (“potential”) hazard for oils infused with an ingredient that has not been acidified.
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 69
Table 1M: Known or reasonably foreseeable (“potential”) food-related biological hazards for Snack Foods
1
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Bread Snacks 1a Baked or Fried Ambient X X
Includes
unseasoned and
seasoned
2
varieties
Bread Snacks 1b Baked with Filling Ambient X X
Includes
unseasoned and
seasoned
2
varieties
Chips and
Crisps
2a
Fried Fruit/
Vegetable
Ambient X X
Includes
unseasoned
3
and
seasoned
2
varieties
Chips and
Crisps
2b
Baked Fruit/
Vegetable
Ambient X X
Includes
unseasoned
3
and
seasoned
2
varieties
Chips and
Crisps
2c
Dehydrated Fruit/
Vegetable
Ambient X X
Includes
unseasoned
3
and
seasoned
2
varieties
Crackers and
Biscuits
3a
- Baked
- Unfilled
Ambient
3
Includes
unseasoned and
seasoned
2
varieties
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 70
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Crackers and
Biscuits
3b
- Baked
- Filled
4
Ambient
Includes
unseasoned and
seasoned
2
varieties
Puffed Snacks 4 Baked or Fried Ambient X X
Includes
unseasoned
3
and
seasoned
2
varieties
Snack Food
Bars
5
- Cold Pressed/
Formed
- With or without
coating
Ambient or
Refrigerated
X X
Includes bars
made with nuts,
fruit, seeds,
chocolate chips
4
Snack Mix 6
Mixed/ Coated
Fruits, Nuts, and
Pretzels
Ambient X X
Includes all
varieties and
coatings
4
Pudding and
Gelatin
Products
7a Dry Mixes Ambient
X X
Includes all
varieties
4
Pudding and
Gelatin
Products
7b Prepared
Ambient
5
or
Refrigerated
X X X X X
Includes all
varieties
4
Frozen
Novelties
8a
Non-Dairy Frozen X X
Includes all
varieties and
coatings
4
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 71
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Frozen
Novelties
8b
Flavored Ices Frozen
Includes all
varieties and
flavors
1
See other Food Groups such as Bakery, Confectionary, Dairy, Grains, Pulses, Flours, and Starches, and Nuts and Seeds for additional Snack Categories such as
cookies, candy, ice cream dairy novelties, mixed nuts, sunflower seeds, and instant noodles.
2
If the product is seasoned after baking or frying, see also Table 1O for known or reasonably foreseeable (“potential”) hazards in spices and herbs that could be
used in the seasoning.
3
The SMEs did not identify any known or reasonably foreseeable (“potential”) biological hazards for
shelf-stable products found in this Food Subcategory
because the products are processed by an “exceptionally lethal process.” (See the discussion of exceptionally lethal processes in section A1.6.1.3.)
4
If the product contains ingredients addressed by other Tables, see the applicable Table as well.
5
Excludes LACF (shelf-stable) products, which are not subject to the requirements for biological hazards in 21 CFR Part 117.
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 72
.
Table 1N: Known or reasonably foreseeable (“potential”) food-related biological hazards for Soups and Sauces
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Soups,
Sauces,
Gravies
1a
Dry Mixes,
Powders
Ambient
X
1
X
1
X
1
X
2
X
2
X
2
Includes all varieties
Soups,
Sauces,
Gravies
1b Base pastes Ambient X
1
X
1
X
1
X
2
X
2
X
2
Includes all varieties
Soups,
Sauces,
Gravies
1c
Full Strength
Liquid or
Condensed
Refrigerated
or Frozen
X
X
X
X
2
X
2
X
2
Includes all varieties
1
The SMEs identified known or reasonably foreseeable (“potential”) biological hazards for sporeformers that would apply only when these products
are rehydrated and/or used as an ingredient in a high-moisture food.
2
In some cases, for vegetative cells of pathogens the cooking step for a product in this Food Subcategory is an exceptionally lethal process. (See
the discussion of exceptionally lethal processes in section A1.6.1.3.) Because some products in this Food Subcategory are produced using
processing that is not an exceptionally lethal process, the SMEs recommended that the vegetative pathogen hazards marked with an X be identified
as known or reasonably foreseeable (“potential”) biological hazards. If the processing step is an exceptionally lethal process, the outcome of the
hazard analysis could be that the listed known or reasonably foreseeable (“potential”) biological hazard does not require a preventive control. Check
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other tables for the major ingredients, because, depending on the ingredients, there may be other hazards, and some of the hazards listed here
may not apply to all products in a Food Subcategory.
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Table 1O: Known or reasonably foreseeable (“potential”) food-related biological hazards for Spices and Herbs
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Spices 1
Dried, Ground,
Cracked, or
Whole
Ambient X
1
X
1
X
1
X
2
Includes cinnamon,
cardamom, turmeric,
paprika, pepper (black,
white, red), cayenne
powder, paprika, chili
powder, cumin, coriander,
mustard, fenugreek,
horseradish, fennel seeds,
caraway, allspice, nutmeg,
ginger, garlic (minced or
powder), onion (minced or
powder), oregano, celery
seed
Herbs 2a Dried Ambient X
1
X
1
X
1
X
2
Includes basil, oregano,
thyme, sage, parsley, bay
leaf, dill, rosemary,
cilantro, mint, kaffir lime,
chives, peppermint
Herbs 2b Fresh
Ambient or
Refrigerated
X
2
X
3
Includes basil, oregano,
thyme, sage, parsley, bay
leaf, dill, rosemary,
cilantro, mint, kaffir lime,
chives, peppermint
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Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C. perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Seasonings 3a Pastes
Ambient or
Refrigerated
X
1
X
1
X
1
X
2
X
3
Includes varieties made
from a single spice or herb
or from multiple spices or
herbs
Seasonings 3b Essential Oils Ambient
Includes essential oil
extracted from any spice or
herb
Seasonings 3c
Spice and
seasoning
mixtures, Dry
or Liquid
Blends
Ambient X
1
X
1
X
1
X
2
Includes all varieties
Seasonings 4 Salt Ambient Includes all varieties
1
The SMEs identified this as a known or reasonably foreseeable (“potential”) biological hazard applicable only when these products are rehydrated
and/or used as an ingredient in a high-moisture food.
2
The SMEs identified Salmonella spp., but not pathogenic E. coli, as a known or reasonably foreseeable (“potential”) biological hazard in this
subcategory based on a 2022 FAO/WHO report (FAO/WHO 2022b).
3
The SME identification of the parasite Cyclospora as a known or reasonably foreseeable (“potential”) biological hazard in this subcategory
primarily applies only to certain herbs (e.g., basil and cilantro), but could also apply to other herbs from areas where Cyclospora has been
determined to be present, e.g., in the water supply.
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Table 1P: Known or reasonably foreseeable (“potential”) food-related biological hazards for Food Sweeteners (Nutritive and
Non-Nutritive)
Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C.
perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Food Sweeteners
(Nutritive and
Non-Nutritive)
1a Sugars (Dry) Ambient
Includes all varieties
Food Sweeteners
(Nutritive and
Non-Nutritive)
1b
Syrup/Molasses
(Liquid)
Ambient
Includes all varieties
Food Sweeteners
(Nutritive and
Non-Nutritive)
1c Honey (Liquid) Ambient X
1
Includes all varieties
and forms (e.g.,
comb, strained,
whipped)
Food Sweeteners
(Nutritive and
Non-Nutritive)
1d
Imitation
Syrup/Molasses
(Liquid)
Ambient
Includes all flavors/
varieties
Food Sweeteners
(Nutritive and
Non-Nutritive)
1e
Sugar Substitutes
(Nutritive)
Ambient
Includes sugar
alcohols, isomalt,
tagatose
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Category # Subcategory
Storage
Conditions
Bacillus cereus
Clostridium botulinum
C.
perfringens
Brucella
spp.
Campylobacter
spp.
Pathogenic
E. coli
Salmonella
spp.
L. monocytogenes
S. aureus
Parasites
Viruses
Comments
Food Sweeteners
(Nutritive and
Non-Nutritive)
1f
Sugar Substitutes
(Non-nutritive)
Ambient
Includes aspartame,
saccharin,
acesulfame K,
neotame, stevia,
sucralose
1
The SMEs identified this as a known or reasonably foreseeable (“potential”) biological hazard applicable only if honey is used as an ingredient in
infant foods.
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A1.11 Tables of Potential Food-Related Chemical Hazards
For consistency with the Tables of Known or Reasonably Foreseeable (“Potential”) Food-Related Biological Hazards (Tables 1A through 1P), we
organized this section around the same 16 Food Groups as those addressed by Tables 1A through 1P. However, in most circumstances a
chemical hazard requiring a preventive control is addressed through a supply-chain program on ingredients used in a food product rather than
through process controls applied during production of the food product. Therefore, we focused the Tables in this section on the food categories and
subcategories containing food products that could be consumed as an ingredient of other food products; in some cases (e.g., Fruits and
Vegetables) these food products also might be consumed as a finished food product. For example, for the purpose of considering biological
hazards, Table 1G (Known or reasonably foreseeable (“potential”) food-related biological hazards for Egg and Egg Products) lists 5 food categories,
including shell eggs. However, for the purpose of considering chemical hazards Table 2G (Known or reasonably foreseeable (“potential”) food-
related chemical hazards for Egg and Egg Products) lists only one of those 5 food categories – i.e., shell eggs; shell eggs would be the source
ingredient of the remaining 4 food categories that are listed in Table 1G for food-related biological hazards.
For 12 of the 16 Food Groups, Tables 2B, 2D, 2E, 2G, 2H, 2I, 2J, 2K, 2O, and 2P list the most relevant food-related chemical hazards and mark
with an X for a Food Subcategory the most relevant food-related chemical hazards that SMEs recommended be identified as known or reasonably
foreseeable hazards ("potential hazards") for subsequent hazard evaluation by each facility that produces food products in those Food
Subcategories to determine which hazards require a preventive control as appropriate to the facility and its food products. As discussed in section
A1.1 of this Appendix, this guidance, including the Tables of Known or Reasonably Foreseeable (“Potential”) Food-Related Chemical Hazards,
consistently uses the combined term “known or reasonably foreseeable hazard (“potential hazard”)” to describe the output of the Tables to
consistently use both the term used in the regulatory text of part 117 and a term that could be more familiar to some users of this guidance.
For four of the 16 Food Groups (i.e., Bakery Items; Dressings, Condiments, and Dips; Snack Foods; and Soups and Sauces) the chemical hazards
depend on the ingredients used. To maintain the overall organization associated with the 16 Food Groups, for these Food Groups we include an
entry for that “Food Group” (i.e., Food Groups 2A, 2F, 2M, and 2N) and advise you to address known or reasonably foreseeable chemical
hazards (“potential chemical hazards”) that might be in the ingredients you use to produce foods in that Food Group.
For three Food Groups (i.e., Tables 2H, 2L, and 2O for Fruits and Vegetables, Oils and Oil Products, and Spices and Herbs, respectively), we
organized the information in the Table around the hazards rather than around the food categories and food subcategories. For example, Table 2H
for Fruits and Vegetables has separate rows directed to pesticides, cadmium, lead, and mycotoxins/other natural toxins. We organized the
information this way because some chemical hazards (such as pesticides in the Fruits and Vegetables Food Group) broadly apply to many foods in
a Food Group, whereas other chemical hazards (such as toxic elements and mycotoxins) more narrowly apply to a subset of foods in a Food
Group.
The Tables of Known or Reasonably Foreseeable (“Potential”) Food-Related Chemical Hazards do not identify any hazards requiring a preventive
control in any Food Subcategory. It is the responsibility of the owner, operator, or agent in charge of each food facility to determine, through hazard
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analysis, whether a chemical hazard identified in these Tables as a known or reasonably foreseeable (“potential”) chemical hazard is a hazard
requiring a preventive control for the facility’s food product.
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Food Group 2A: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Bakery Items
This Appendix does not include a Table of known or reasonably foreseeable (“potential”) food-related chemical hazards for Bakery Items. Instead,
for known or reasonably foreseeable (“potential”) food-related chemical hazards for Bakery Items, you should see the Table(s) associated with the
ingredients in your Bakery Item. For example:
• If your Bakery Item contains chocolate, you should consult Table 2D regarding known or reasonably foreseeable (“potential”) food-related
chemical hazards for Chocolate and Candy.
• If your Bakery Item contains eggs, you should consult Table 2G regarding known or reasonably foreseeable (“potential”) food-related chemical
hazards for Egg and Egg Products.
• If your Bakery Item contains wheat flour, you should consult Table 2J regarding known or reasonably foreseeable (“potential”) food-related
chemical hazards for Grains, Pulses, Flours, and Starches.
• If your Bakery Item contains fruit, you should consult Table 2H regarding known or reasonably foreseeable (“potential”) food-related chemical
hazards for Fruits and Vegetables.
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Table 2B: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Beverage Items
Category # Subcategory
Storage
Conditions
Drug residues
Arsenic
cadmium
Lead
Mycotoxins/
Natural toxins
Pesticides
Comments
Non-dairy
Cocoa/
Chocolate
1
- Ready-to-Drink
- Powdered
Ambient and
Refrigerated
X X X
1
Includes plant-based
chocolate/ cocoa
flavored products
Coffee 2
- Raw and Roasted
Beans/ Whole or
Ground
- Single Serve
- Ready-to-Drink
- Powdered
- Freeze-Dried
Ambient X
1
Includes flavored and
unflavored varieties
Tea 6
- Loose Leaf and
Bagged
- Tea and Tea
Substitutes
Ambient X
Includes plain and
flavored teas and herbal
teas
Carbonated
Beverages
7
Ready-to-Drink /
Carbonated Plain
and Flavored
Ambient X
Includes plain and
flavored varieties
Ground
Coffee
Substitutes
12 Dry Powdered Ambient X
2
Includes chicory root
powder, roasted grains
1
The applicable mycotoxin is ochratoxin. (See FDA Compliance Program 7307.001 (in Table 5 in section VI of the Introduction of this guidance) and Codex Code
of Practice CAC/RCP 69-2009 and CAC/RCP 72-2013 (in Table 6 in section VI of the Introduction of this guidance).)
2
The applicable mycotoxin depends on the grain. For the applicable mycotoxin for a specific grain, see Table 1J.
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Table 2C: Food Additives, Color Additives, and GRAS Substances
Category # Subcategory
Storage
Conditions
Drug residues
Arsenic
Cadmium
Lead
Mycotoxins/
Natural toxins
Pesticides
Comments
Nutrients 7
Vitamins,
Minerals, and
Vitamin/Mineral
Premixes
Ambient or
Refrigerated
X
1
X
1
The specific vitamin or
mineral that could be
contaminated with arsenic
or lead is not yet identified.
1
Bair, EC, 2022.
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Table 2D: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Chocolate and Candy
Category # Subcategory
Storage
Conditions
Drug residues
Arsenic
Cadmium
Lead
Mycotoxins/
Natural toxins
Pesticides
Comments
Chocolate
Industrial Products
1a
Raw Cocoa
Beans
Ambient X X X
1
Cocoa Beans
Chocolate
Industrial Products
1b
Roasted Cocoa
Beans and Nibs,
Cocoa Butter,
Cocoa Powder
Ambient X X X
1
Beans and Nibs
1
The applicable mycotoxin is ochratoxin. (See FDA Compliance Program 7307.001 (in Table 5 in section VI of the Introduction of this guidance) and Codex Code
of Practice CAC/RCP 72-2013 (in Table 6 in section VI of the Introduction of this guidance).)
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Table 2E: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Dairy
Category # Subcategory
Storage
Conditions
Drug residues
Arsenic
Cadmium
Lead
Mycotoxins/
Natural toxins
Pesticides
Comments
All 1, 2, 3, 4, 5 All
Ambient,
Refrigerated,
and Frozen
X
Includes all products
described in Table 1E, as
well as shelf stable and
aseptically processed and
packaged milk and milk
products that are
produced in accordance
with our LACF regulation
in 21 CFR part 113
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Food Group 2F: Dressings, Condiments, and Dips
This Appendix does not include a Table of known or reasonably foreseeable (“potential”) food-related chemical hazards for Dressings, Condiments,
and Dips. Instead, for known or reasonably foreseeable (“potential”) food-related chemical hazards for Dressings, Condiments, and Dips, you
should see the Table(s) associated with the ingredients in your Dressing, Condiment or Dip Item. For example:
• If your Dressing, Condiment, or Dip contains dairy ingredients, you should consult Table 2D regarding known or reasonably foreseeable
(“potential”) food-related chemical hazards for Dairy.
• If your Dressing, Condiment, or Dip contains eggs, you should consult Table 2G regarding known or reasonably foreseeable (“potential”) food-
related chemical hazards for Egg and Egg Products.
• If your Dressing, Condiment, or Dip contains flour or a pulse such as chickpeas, you should consult Table 2J regarding known or reasonably
foreseeable (“potential”) food-related chemical hazards for Grains, Pulses, Flours, and Starches.
• If your Dressing, Condiment, or Dip contains a fruit or vegetable, you should consult Table 2H regarding known or reasonably foreseeable
(“potential”) food-related chemical hazards for Fruits and Vegetables.
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Table 2G: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Egg and Egg Products
Category # Subcategory
Storage
Conditions
Drug residues
Arsenic
Cadmium
Lead
Mycotoxins/
Natural toxins
Pesticides
Comments
Shell Eggs 1
Shell Eggs - Raw
and Pasteurized
in Shell
Refrigerated X Includes all shell eggs
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Table 2H: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Fruits and Vegetables
1
Category #
1
Subcategory
Storage
Conditions
Drug residues
Arsenic
Cadmium
Lead
Mycotoxins/
Natural toxins
Pesticides
Comments
Fruits and
vegetables
All
Whole RAC
or processed
Ambient or
Refrigerated
X All fruits and vegetables
Fruits and
vegetables
All
Whole RAC
or processed
Ambient or
Refrigerated
X
Includes spinach, lettuce,
potatoes, beets
Fruits and
vegetables
All
Whole RAC
or processed
Ambient or
Refrigerated
X
Includes sweet potatoes,
carrots, spinach, dried
plums (prunes), potatoes,
mushrooms, garlic
Fruits and
vegetables
All
Whole RAC
or processed
Ambient or
Refrigerated
X
2
Includes apple products,
dried fruits, dried beans and
peas
1
Known or reasonably foreseeable (“potential”) chemical hazards generally apply to a raw agricultural commodity regardless of whether and how it
is processed. Therefore, each row in Table 2H applies to “fruits and vegetables,” regardless of whether they are whole RACs or processed as
described in Table 1H regarding known or reasonably foreseeable (“potential”) biological hazards. The difference between each row is the chemical
hazard that is listed as a known or reasonably foreseeable (“potential”) chemical hazard.
2
For apples and apple products, the applicable mycotoxin is patulin. For dried fruits the applicable mycotoxins are aflatoxin (dried figs) (FDA Import
Alert 23-14; see Table 5 in section VI of the Introduction of this guidance) or ochratoxin A (raisins, dried figs) (FDA Compliance Program 7307.001;
see Table 5 in section VI of the Introduction of this guidance). For dried vegetable (beans and peas) the applicable mycotoxin is ochratoxin A (FDA
Compliance Program 7307.001; see Table 5 in section VI of the Introduction of this guidance).
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Table 2I: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Game Meat Products
Category # Subcategory
Storage
Conditions
Drug residues
Arsenic
Cadmium
Lead
Mycotoxins/
Natural toxins
Pesticides
Comments
Raw Game Meat All
Ground and Not
Ground Game
Meat
Refrigerated or
Frozen
X
1
Bison Steak, Deer
Shoulder, Rabbit, and Birds
(Pheasant, Grouse, Quail)
1
The SMEs identified known or reasonably foreseeable (“potential”) drug residue hazards in the broad category “Game Meat Products” but did not
differentiate between species (e.g., bison, deer, rabbit). You can search for drug approvals by species using the advanced search feature on our
website at https://animaldrugsatfda.fda.gov/
. (See Table 8 in section VI of the Introduction of this guidance.) You can find tolerances for approved
animal drugs in 21 CFR Part 556.
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Table 2J: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Grains, Pulses, Flours, and
Starches
Category # Subcategory
Storage
Conditions
Drug residues
Arsenic
Cadmium
Lead
Mycotoxins/
Natural toxins
Pesticides
Comments
Grains,
Non-Rice
1
Whole and
milled grains
(e.g., flour and
bran)
Ambient X
1
X
Wheat, Rye, Sorghum, Oats, Barley, Triticale,
Buckwheat, Corn, Amaranth, Millet, Quinoa
(RACs and milled grain products)
Rice,
Milled Rice
Products
2b
Rice (whole
and milled)
and rice
products
Ambient X X
X
2
X
White or Brown Rice, Rice protein,
Sticky/sweet Rice, Basmati Rice, Jasmine
Rice, Arborio rice, Rice-based noodles, Rice-
based cereal
Other
Milled
Products
5a Root flours Ambient X
3
Potato flour, Cassava flour
Other
Milled
Products
5a Root flours Ambient X Sweet potato flour, yam flour
Pulses 6a
Whole (dried)
or processed
Ambient X
4
X
Soybean, Kidney, Pinto, Navy, Azuki, Mung,
Black Gram, Dried Peas; Chickpea;
Cowpea/Black-eyed Pea; Lentil; Winged Bean
1
The applicable mycotoxins are ochratoxin A (oats, wheat, barley), aflatoxin (dried corn), fumonisins (dried corn), and deoxynivalenol/ vomitoxin (wheat, barley)
(See CPG Sec. 555.400 (in Table 3 in section VI of the Introduction of this guidance); Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products for
Human Consumption and Grains and Grain By-Products used for Animal Feed (in Table 4 in section VI of the Introduction of this guidance); FDA Compliance
Program 7307.001 (in Table 5 in section VI of the Introduction of this guidance); and Import Alert 23-14 (in Table 5 in section VI of the Introduction of this
guidance).)
2
Aflatoxin is the applicable mycotoxin (only for raw brown rice).
3
Cassava contains cyanogenic glycosides that produce cyanide. Depending on the level of cyanogenic glycosides, cassava is detoxified by heat processing alone,
or by a combination of heat processing and food preparation techniques such as peeling, soaking, sun-drying, and scraping off the outer layer to leach out the
cyanide (Canadian Food Inspection Agency, 2019).
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4
The applicable mycotoxin is ochratoxin A for dried peas and beans. (See FDA Compliance Program 7307.001 (in Table 5 in section VI of the Introduction of this
guidance).)
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Table 2K: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Nuts and Seeds
Category # Subcategory
Storage
Conditions
Drug residues
Arsenic
Cadmium
Lead
Mycotoxins/
Natural toxins
Pesticides
Comments
Nuts 1a
Peanuts, Raw
and treated
Ambient X
1
X Peanuts
Nuts 1c
Tree Nuts, Raw
and treated
Ambient X
1
All tree nuts
Nuts 1c
Tree Nuts, Raw
and treated
Ambient X Cashews and pecans
Edible Seeds 2a Raw and treated Ambient X
1
X Melon, Pumpkin, Sunflower
Edible Seeds 2a Raw and treated Ambient X Sunflower
1
The applicable mycotoxin is aflatoxin. (See CPG Sec. 570.200, CPG Sec. 570.375, and CPG Sec. 570.500 in Table 3 in section VI of the Introduction of this
guidance.)
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Table 2L: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Oils and Oil Products
Category # Subcategory
Storage
Conditions
Drug residues
Arsenic
Cadmium
Lead
Mycotoxins/
Natural toxins
Pesticides
Comments
Oil products
1a
1d
Highly refined cooking
oils and infused oils
Ambient
See the discussion in section
A1.7.2 that the chemical
hazards 3-monochloropropane-
1,2-diol esters (3-MCPDEs) and
glycidyl esters (GEs) have the
potential to form in refined oils
during food production,
particularly at high temperature.
Oil products 1a
Cooking oils that are
not highly refined
(e.g., produced
through cold pressing)
Ambient X Includes olive oil
Oil products
1a
1d
Cooking oils and
infused oils that are
not highly refined
(e.g., produced
through cold pressing)
Ambient X
1
Includes cold-pressed oil and
flavored oils from peanuts, tree
nuts, sesame, sunflower, and
melon
1
The applicable mycotoxin is aflatoxin (Einolghozati et al., 2021; Sahin et al., 2022; and Table 2K).
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Food Group 2M: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Snack Foods
This Appendix does not include a Table of known or reasonably foreseeable (“potential”) food-related chemical hazards for Snack Foods. Instead,
for known or reasonably foreseeable (“potential”) food-related chemical hazards for Snack Foods, you should see the Table(s) associated with the
ingredients in your Snack Food. For example:
• If your Snack Food contains chocolate, you should consult Table 2D regarding known or reasonably foreseeable (“potential”) food-related
chemical hazards for Chocolate and Candy.
• If your Snack Food contains a fruit or vegetable, you should consult Table 2H regarding known or reasonably foreseeable (“potential”) food-
related chemical hazards for Fruits and Vegetables.
• If your Snack Food contains wheat flour, you should consult Table 2J regarding known or reasonably foreseeable (“potential”) food-related
chemical hazards for Grains, Pulses, Flours, and Starches.
• If your Snack Food contains peanuts or tree nuts, you should consult Table 2K regarding known or reasonably foreseeable (“potential”) food-
related chemical hazards for Nuts and Seeds.
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Food Group 2N: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Soups and Sauces
This Appendix does not include a Table of known or reasonably foreseeable (“potential”) food-related chemical hazards for Soups and Sauces.
Instead, for known or reasonably foreseeable (“potential”) food-related chemical hazards for Soups and Sauces, you should see the Table(s)
associated with the ingredients in your Soup or Sauce. For example:
• If your Soup or Sauce contains a dairy item, you should consult Table 2E regarding known or reasonably foreseeable (“potential”) food-related
chemical hazards for Dairy.
• If your Soup or Sauce contains a fruit or vegetable, you should consult Table 2H regarding known or reasonably foreseeable (“potential”) food-
related chemical hazards for Fruits and Vegetables.
• If your Soup or Sauce contains wheat flour, you should consult Table 2J regarding known or reasonably foreseeable (“potential”) food-related
chemical hazards for Grains, Pulses, Flours, and Starches.
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Table 2O: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Spices and Herbs
Category # Subcategory
Storage
Conditions
Drug residues
Arsenic
Cadmium
Lead
Mycotoxins/
Natural toxins
Pesticides
Comments
Spices 1
Dried, Ground,
Cracked, or Whole
Ambient X
Includes capsicums (which include
cayenne, chili, paprika), cumin
Spices 1
Dried, Ground,
Cracked, or Whole
Ambient X
Includes chili powder, cumin,
oregano
Spices 1
Dried, Ground,
Cracked, or Whole
Ambient X
Includes chilis/chili powder, cumin,
oregano
Spices 1
Dried, Ground,
Cracked, or Whole
Ambient X
1
Includes aniseed, chili powder,
cinnamon, coriander, cumin, curry,
ginger, five spice, red hot pepper,
turmeric
Spices 1
Dried, Ground,
Cracked, or Whole
Ambient X
2
Includes capsicums (which include
cayenne, chili, paprika), ginger,
nutmeg, turmeric
Herbs 2a Fresh and Dried Ambient X
Includes basil, bay leaves,
tarragon, thyme
1
See Ishida et al. 2022.
2
The applicable mycotoxins are aflatoxin and ochratoxin A. (See Compliance Program 7307.001 in Table 5 in section VI of the Introduction of this guidance; Iha
and Truckness, 2019; and Kabak and Dobson, 2017.)
Contains Non-binding Recommendations
Draft-Not for Implementation
Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 96
Table 2P: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Food Sweeteners (Nutritive and
Non-Nutritive)
Category # Subcategory
Storage
Conditions
Drug residues
Arsenic
Cadmium
Lead
Mercury
Mycotoxins/
Natural toxins
Pesticides
Comments
Food Sweeteners
(Nutritive and
Non-Nutritive)
1c Honey (Liquid) Ambient X
X
Includes all
varieties and forms
(e.g., comb,
strained, whipped)
Contains Non-binding Recommendations
Draft-Not for Implementation
Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 97
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